mmr2.jpg (14773 bytes)

With the Genuine Jeryl Lynn Mumps Strain

MMRII

(Measles, Mumps, and Rubella Virus Vaccine Live, MSD)

DESCRIPTION

M-M-R* II (Measles, Mumps, and Rubella Virus Vaccine Live, MSD) is a live virus vaccine for immunisation against measles (rubeola), mumps and rubella (German measles).

M-M-R II is a sterile lyophilized preparation of (1) ATTENUVAX* (Measles Virus Vaccine Live, MSD), a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and grown in cell cultures of chick embryo; (2) MUMPSVAX* (Mumps Virus Vaccine Live, MSD), the Jeryl Lynn (B level) strain of mumps virus grown in cell cultures of chick embryo; and (3) MERU-VAX* II (Rubella Virus Vaccine Live, MSD), the Wistar RA 27/3 strain of live attenuated rubella virus grown in human diploid cell (Wl-38) culture1,2.: The vaccine viruses are the same as those used in the manufacture of ATTENUVAX (Measles Virus Vaccine Live, MSD), MUMPSVAX (Mumps Virus Vaccine Live, MSD) and MERUVAX II (Rubella Virus Vaccine Live, MSD). The three viruses are mixed before being lyophilized. The product contains no preservative.

The reconstituted vaccine is for subcutaneous administration. When reconstituted as directed, the dose for injection is 0.5 mL and contains not less than the equivalent of 1,000 CCID„, (50% cell culture infective dose) of measles virus; 5,000 CCID,, of mumps virus; and 1,000 CCID,, of rubella virus. Each dose of the vaccine contains sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), human albumin (0.3 mg), foetal bovine serum (<1 ppm), other buffer and media ingredients and approximately 25 mcg of neomycin. The product contains no preservative.

CLINICAL PHARMACOLOGY

Clinical studies of 279 triple seronegative children, 11 months to 7 years of age, demonstrated that M-M-R II is highly immunogenic and generally well tolerated. In these studies, a single injection of the vaccine induced measles haemagglutination-inhibition (HI) antibodies in 95 percent, mumps neutralizing antibodies in 96 percent, and rubella Hl antibodies in 99 percent of susceptible persons.

The RA 27/3 rubella strain in M-M-R II elicits higher immediate post-vaccination Hl, complement-fixing and neutralizing antibody levels than other strains of rubella vaccine3-9 and has been shown to induce a broader profile of circulating antibodies including anti-theta and anti-iota precipitating antibodies.10 The RA 27/3 rubella strain immunologically simulates natural infection more closely than other rubella vaccine viruses.11-13 The increased levels and broader profile of antibodies produced by RA 27/3 strain rubella virus vaccine appear to correlate with greater resistance to subclinical reinfection with the wild virus,11, 13-15 and provide greater confidence for lasting immunity.

Vaccine induced antibody levels following administration of M-M-R II have been shown to persist for over 11 years.40

 

INDICATIONS AND USAGE

M-M-R II is indicated for simultaneous immunisation against measles, mumps, and rubella in persons 12 to 15 months of age or older. A second dose of M-M-R II or monovalent measles vaccine is recommended (see Revaccination)16,17,18

Infants who are less than 15 months of age may fail to respond to the measles component of the vaccine due to presence in the circulation of residual measles antibody of maternal origin, the younger the infant, the lower the likelihood of seroconversion. In geographically isolated or other relatively inaccessible populations for whom immunisation programs are logistically difficult, and in population groups in which natural measles infection may occur in a significant proportion of infants before 12 months of age, it may be desirable to give the vaccine to infants at an earlier age. Infants vaccinated under these conditions at less than 12 months of age should be revaccinated at between 12 to 15 months of age providing that 3 months have elapsed since the initial injection of measles vaccine. Most infants 12-14 months of age respond readily, but a booster on school entry or later may be needed to avoid breakthrough cases in these infants.41There is some evidence to suggest that infants immunised at less than one year of age may not develop sustained antibody levels when later reimmunised. The advantage of early protection must be weighed against the chance for failure to respond adequately on reimmunisation.19

Previously unimmunised children of susceptible pregnant women should receive live attenuated rubella vaccine, because an immunised child will be less likely to acquire natural rubella and introduce the virus into the household.

Individuals planning travel abroad, if not immune, can acquire measles, mumps or rubella and import these diseases to their country. Therefore, prior to International travel, individuals known to be susceptible to one or more of these diseases can receive either a single antigen vaccine (measles, mumps or rubella), or a combined antigen vaccine as appropriate. However, M-M-R II is preferred for persons likely to be susceptible to mumps and rubella as well as measles; and if single-antigen measles vaccine is not readily available, travellers should receive M-M-R II regardless of their immune status to mumps or rubella.20,21,22

NON-PREGNANT ADOLESCENT AND ADULT FEMALES

Immunisation of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see below and PRECAUTIONS). Vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the foetus and consequent congenital rubella injury.‘

Women of childbearing age should be advised not to become pregnant for three months after vaccination and should be informed of the reasons for this precaution.*

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’NOTE: The Immunisation Practices Advisory Committee (ACIP) has recommended "In view of the importance of protecting this age group against rubella, reasonable precautions in a rubella immunisation program include asking females if they are pregnant, excluding those who say they are, and explaining the theoretical risks to the others.23

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It is recommended that rubella susceptibility be determined by serologic testing prior to immunisation.* If immune, as evidenced by a specific rubella antibody titer of 1:8 or greater (haemagglutination inhibition test), vaccination is unnecessary. Congenital malformations do occur in up to seven percent of all live births.24 Their chance appearance after vaccination could lead to misinterpretation of the cause, particularly if the prior rubella-immune status of vaccinees is unknown.

Postpubertal females should be informed of the frequent occurrence of generally self-limited arthralgia and/or arthritis beginning 2 to 4 weeks after vaccination (see ADVERSE REACTIONS).

 

POSTPARTUM WOMEN

It has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period (See Nursing Mothers).

 

REVACCINATION

Children first vaccinated when younger than 12 months of age should be revaccinated at 15 months of age.

A number of national, governmental vaccine authorities, the American Academy of Pediatrics (AAP), and the Immunisation Practices Advisory Committee (ACIP), have recommended guidelines for routine measles revaccination and to help control measles outbreaks.25,26,42

Vaccines available for revaccination include monovalent measles vaccine [ATTENUVAX (Measles Virus Vaccine Live, MSD)] and polyvalent vaccines containing measles [e.g, M-M-R II, M-R-VAX+ II (Measles and Rubella Virus Vaccine Live, MSD), M-M-VAX+ (Measles and Mumps Virus Vaccine Live, MSD)]. If the prevention of sporadic measles outbreaks is the sole objective, revaccination with a monovalent measles vaccine should be considered (see appropriate product circular). If concern also exists about immune status regarding mumps or rubella, revaccination with appropriate monovalent or polyvalent vaccine should be considered after consulting the appropriate product circulars. Unnecessary doses of a vaccine are best avoided by ensuring that written documentation of vaccination is preserved and a copy given to each vaccinee's parent or guardian.

__________________________________________________________________

 

"NOTE: The immunisation Practices Advisory Committee <ACIP) has stated "When practical, and when reliable laboratory services are available, potential vaccinees of childbearing age can have serologic tests to determine susceptibility to rubella .... However, routine/y performing serologic tests for all females of childbearing age to determine susceptibility so that vaccine is given only to proven susceptibles is expensive and has been ineffective in some areas. Accordingly, the ACIP believes that rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing.23

""NOTE: A primary difference among these recommendations is the timing of revaccination: the ACIP recommends routine revaccination at entry into kindergarten or first grade, whereas the AAP recommends routine revaccination at entrance to middle school or junior high school. In addition, some public health jurisdictions mandate the age for revaccination. The complete text of applicable guidelines should be consulted.25, 26

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USE WITH OTHER VACCINES

M-M-R II should be given one month before or after administration of other vaccines.

However, other schedules have been used. For example, the AAP has noted that when the patient may not return, some practitioners prefer to administer DTP, OPV, and M-M-R II on a single day. If done, separate sites and syringes should be used for DTP and M-M-R II.27 The ACIP recommends routine simultaneous administration of M-M-R II, DTP and OPV or inactivated polio vaccine (IPV) to all children > 15 months who are eligible to receive these vaccines on the basis that there are equivalent antibody responses and no clinically significant increases in the frequency of adverse events when DTP, M-M-R II and OPV or IPV are administered either simultaneously at different sites or separately.* Administration of M-M-R II at 15 months followed by DTP and OPV (or IPV) at 18 months remains an acceptable alternative, especially for children with caregivers known to be generally compliant with other health-care recommendations.

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'NOTE: The ACIP recommends administering MM-R II concomitantly with the fourth dose of DTP and the third dose of OPV to children l5 months of age or older providing that 6 months have elapsed since DTP-3; or, if fewer than three DTPs have been received, at least 6 weeks have elapsed since the last dose of DTP and OPV.

CONTRAINDICATIONS

Do not give M-M-R II to pregnant females; the possible effects of the vaccine on foetal development are unknown at this time. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for three months following vaccination. (See PRECAUTIONS, Pregnancy).

Anaphylactic or anaphylactoid reactions to neomycin (each dose of reconstituted vaccine contains approximately 25 mcg of neomycin).

History of anaphylactic or anaphylactoid reactions to eggs (see HYPERSENSITIVITY TO EGGS).

Any febrile respiratory illness or other active febrile infection.

Active untreated tuberculosis.

Patients receiving immunosuppressive therapy. This contraindication does not apply to patients who are receiving corticosteroids as replacement therapy, e.g, for Addison's disease.

Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.

Primary and acquired immunodeficiency states, including patients who are immunosuppressed in association with AIDs or other clinical manifestations of infection with human immunodeficiency viruses; 28,29 cellular immune deficiencies, hypogammaglobuline mic and dysgammaglobulinemic states.

Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.30

 

HYPERSENSITIVITY TO EGGS

Live measles vaccine and live mumps vaccine are produced in chick embryo cell culture. Persons with a history of anaphylactic, anaphylactoid or other immediate reactions (e.g. hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion should not be vaccinated. Evidence indicates that persons are not at increased risk if they have egg allergies that are not anaphylactic or anaphylactoid in nature. Such persons may be vaccinated in the usual manner. There is no evidence to indicate that persons with allergies to chickens or feathers are at increased risk of reaction to the vaccine."

 

PRECAUTIONS

GENERAL

Adequate treatment provisions including epinephrine, should be available for irnrnediate use should an anaphylactic or anaphylactoid reaction occur.

Due caution should be employed in administration of M-M-R Il to persons with individual or family histories of convulsions, or a history of cerebral injury or any other condition in which stress due to fever should be avoided. The physician should be alert to the temperature elevation which may occur following vaccination. (See ADVERSE REACTIONS).

Children and young adults who are known to be infected with human immunodeficiency viruses but without overt clinical manifestations of immunosuppression may be vaccinated; however, the vaccinees should be monitored closely for exposure to vaccine-preventable diseases because irnmunisation may be less effective than for uninfected persons.28 29 In selected cases confirmation of circulating antibody levels may be indicated to help guide appropriate protective measures, including immunoprophylaxis if immunity has waned to non-protective levels.

Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of human immune serum globulin.

Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7-28 days after vaccination. There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals. Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk." However, transmission of the rubella vaccine virus to infants via breast milk has been documented (see Nursing Mothers).

There are no reports of transmission of live attenuated measles or mumps viruses from vaccinees to susceptible contacts.

It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin test is to be done, it should be administered either before or simultaneously with M-M-R II.

Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunised with live measles virus vaccine;31 no studies have been reported to date of the effect of measles virus vaccines on untreated tuberculous children.

As for any vaccine, vaccination with M-M-R II may not result in seroconversion in 100% of susceptible persons given the vaccine.

 

PREGNANCY

Animal reproduction studies have not been conducted with M-M-R II. It is also not known whether M-M-R II can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, the vaccine should not be administered to pregnant females; furthermore, pregnancy should be avoided for three months following vaccination (see CONTRAINDICATIONS).

In counselling women who are inadvertently vaccinated when pregnant or who become pregnant within 3 months of vaccination, the physician should be aware of the following: (1) In a 10 year survey involving over 700 pregnant women who received rubella vaccine within 3 months before or after conception (of whom 189 received the Wistar RA 27/3 strain), none of the newborns had abnormalities compatible with congenital rubella syndrome;32 (2) Although mumps virus is capable of infecting the placenta and foetus, there is no good evidence that it causes congenital malformations in humans.

Mumps vaccine virus also has been shown to infect the placenta, but the virus has not been isolated from the foetal tissues from susceptible women who were vaccinated and underwent elective abortions;33 and (3) Reports have indicated that contracting of natural measles during pregnancy enhances foetal risk. Increased rates of spontaneous abortion, stillbirth, congenital defects and prematurity have been observed subsequent to natural measles during pregnancy. There are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy. However, it would be prudent to assume that the vaccine strain of virus is also capable of inducing adverse foetal effects.

 

NURSING MOTHERS

It is not known whether measles or mumps vaccine virus is secreted in human milk. Recent studies have shown that lactating postpartum women immunised with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants.34 In the infants with serological evidence of rubella infection, none exhibited severe disease; however, one exhibited mild clinical illness typical of acquired rubella.35,36 Caution should be exercised when M-M-R II is administered to a nursing woman.

 

ADVERSE REACTIONS

The adverse reactions associated with the use of M-M-R II are those which have been reported following administration of the monovalent vaccines.

COMMON

Burning and/or stinging of short duration at the injection site.

OCCASIONAL

 

Body as a whole

Fever (101 deg F [38. 3 deg C] or higher)

 

Skin

Rash, usually minimal but may be generalized.

Generally, fever, rash, or both appear between the 5th and the 12th days.

RARE

 

Body as a whole

Mild local reactions such as erythema, induration and tenderness; sore throat, malaise.

 

Digestive

Parotitis, nausea, vomiting, diarrhoea.

 

Haematologic/Lymphatic

Regional lymphadenopathy, thrombocytopenia, purpura.

 

Hypersensitivity

Allergic reactions such as wheal and flare at injection site, anaphylaxis and anaphyiactoid reactions, urticaria.

 

Musculoskeletal

Arthralgia and/or arthritis (usually transient and rarely chronic [see below]), myalgia.

 

Nervous/psychiatric

Febrile convulsions in children, afebrile convulsions or seizures, headache, dizziness, paresthesia, polyneuritis, Guillain-Barre syndrome, ataxia. Encephalitis/encephalopathy have been reported approximately once for every 3 million doses.40 In no case has it been shown that reactions were actually caused by vaccine. The risk of such serious neurological disorders following live measles virus vaccine administration remains far less than that for encephalitis and encephalopathy with natural measles (one per two thousand reported cases).

 

Skin

Erythema multiforme.

 

Special senses

Forms of optic neuritis, including retrobulbar neuritis, papillitis, and retinitis; ocular palsies, otitis media, nerve deafness, conjunctivitis.

 

Urogenital

Orchitis

There have been reports of subacute sclerosing panencephalitis (SSPE) in children who did not have a history of natural measles but did receive measles vaccine. Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination. Based on estimated nationwide measles vaccine distribution, the association of SSPE cases to measles vaccination is about one case per million vaccine doses distributed. This is far less than the association with natural measles, 6-22 cases of SSPE per million cases of measles. The results of a retrospective case-controlled study conducted by the Centre for Disease Control suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent higher risk of SSPE.37Local reactions characterized by marked swelling, redness and vesiculation at the injection site of attenuated live measles virus vaccines, and systemic reactions including atypical measles, have occurred in persons who received killed measles vaccine previously. M-M-R II was not given under this condition in clinical trials. Rarely, more severe reactions that require hospitalization, including prolonged high fevers and extensive local reactions, have been reported.38 Panniculitis has been reported rarely following administration of measles vaccine.39

Arthralgia and/or arthritis (usually transient and rarely chronic), and polyneuritis are features of natural rubella and vary in frequency and severity with age and sex, being greatest in adult females and least in prepubertal children. Chronic arthritis has been associated with natural rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues. Only rarely have vaccine recipients developed chronic joint symptoms.

Following vaccination in children, reactions in joints are uncommon and gener ally of br ief duration. In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (children: 0-3%; women: 12-20%)40, and the reactions tend to be more marked and of longer duration. Symptoms may persist for a matter of months or on rare occasions for years. In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and in adult women. Even in older women (35-45 years), these reactions are generally well tolerated and rarely interfere with normal activities. Such reactions occur much less frequently after revaccination than primary vaccination.40

FOR SUBCUTANEOUS ADMINISTRATION Do not inject intravenously

The dosage of vaccine is the same for all persons. Inject the total volume of the single dose vial (about 0.5 mL) or 0.5 mL of the 10 dose vial of reconstituted vaccine subcutaneously, preferably into the outer aspect of upper arm. Do not give immune globulin (IG) concurrently with M-M-R II.

During shipment to insure that there is no loss of potency, the vaccine must be maintained at a temperature of 2-8"C (35.6-46.4"F).

Before reconstitution, store M-M-R II at 2-8"C (35.6-46.4"F). Protect from light.

CAUTION: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and/or reconstitution of the vaccine because these substances may inactivate the live virus vaccine. A 25 gauge, 5/8" needle is recommended.

To reconstitute, use only the diluent supplied, since it is free of preservatives or other antiviral substances which might inactivate the vaccine.

 

SINGLE DOSE VIAL

First withdraw the entire volume of diluent into the syringe to be used for reconstitution. Inject all the diluent in the syringe into the vial of lyophiiized vaccine, and agitate to mix thoroughly. Withdraw the entire contents into a syringe and inject the total volume of restored vaccine subcutaneously.

It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of hepatitis B and other infectious agents from one person to another.

 

10 DOSE VIAL (AVAILABLE ONLY TO GOVERNMENT AGENCIES/ INSTITUT IONS )

Withdraw the entire contents (7 mL) of the diluent vial into the sterile syringe to be used for reconstitution, and introduce into the 10 dose vial of lyophilized vaccine. Agitate to ensure thorough mixing. The outer labelling suggests "For Jet Injector or Syringe Use". Use with separate sterile syringes is permitted for containers of 10 doses or less. The vaccine and diluent do not contain preservatives; therefore, the user must recognize the potential contamination hazards and exercise special precautions to protect the sterility and potency of the product. The use of aseptic techniques and proper storage prior to and after restoration of the vaccine and subsequent withdrawal of the individual doses is essential. Use 0.5 mL of the reconstituted vaccine for subcutaneous injection.

It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of hepatitis B and other infectious agents from one person to another.

Parenteral medicine products should be inspected visually for particulate matter and discoloration prior to administration. M-M-R II when reconstituted, is clear yellow.

 

No. 4749 M-M-R II is supplied as a single dose vial of lyophilized vaccine, NDC 0006-4749-00, and a vial of diluent.

No. 4681-4309 - M-M-R II is supplied as follows ('I) a box at 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4681-00; and (2) a box of 10

vials of diluent (package B). To conserve refrigerator space, the diluent may be stored separately at room temperature.

 

AVAILABLE ONLY TO GOVERNMENT AGENCIES/INSTITUTIONS

No. 4682X M-M-R II is supplied as one 10 dose vial of lyophilized vaccine, NDC 0006-4682-00, and one 7 mL vial of diluent.

 

Before reconstitution, store M-M-R II at 2-8’ C (35.6-46.4"F). Protect from light.

M-M-R II retains at least 8 times the minimum immunizing dose even after 6 weeks at 22'C or 1 week at 37"C. Storage at temperatures above 2 to 8'C cannot be recommended due to the difficulty in monitoring the exact temperature and monitoring repeated exposures to time out of refrigeration.

It is recommended that the vaccine be used as soon as possible after reconstitution. Protect vaccine from light at all times, since such exposure may inactivate the virus. Store reconstituted vaccine in the vaccine vial in a dark place at 2-8"C (35.6-46.4" F) and discard if not used within 8 hours.

Prior to reconstitution the vaccine has a shelf life of 24 months when stored at 2-8"C and protected from light.

 

1 Plotkin, 5.A; Cornfeld, D.; Ingalls, T.H.: Studies of immunisation with living rubella virus; Trials in children with a strain cultured from an aborted foetus, Am. J. Dis. Child. 110: 381-389, 1965.

2 Plotkin, 5.A.; Farquhar, J.; Katz, M.; Ingalls, T.H.: A new attenuated rubella virus grown in human fibroblasts: Evidence for reduced nasopharyngeal excretion, Am. J. Epidemiol. 86; 468-477, 1967.

3 Fogel, A.; Moshkowitz, A.; Rannon, L.; Gerichter, Ch.B: Comparative Trials of RA27/3 and Cendehill rubella vaccines in adult and adolescent females, Am. J. Epidemiol. 93: 392-393, 1971.

4 Andzhaparidze, O.G.; Desyatskova, R.G.;

Chervonski, G.l.; Pryanichnikova, L.V.:

Immunogenicity and reactogenicity of live attenuated rubella virus vaccines, Am. J. Epidemiol. 91; 527-530, 1970.

5 Freestone, D.S.; Reynolds, G.M.; McKinnon, J.A.; Prydie, J.: Vaccination of schoolgirls against rubella. Assessment of serological status and a comparative trial of Wistar RA 27/3 and Cendehill strain live attenuated rubella vaccines in 13-year-old schoolgirls in Dudley, Br. J. Prev. Soc. Med. 29: 258-261, 1975.

6 Grillner, L.; Hedstrom, C.E.; Bergstrom, N.; Forssman, L.; Rigner, A.; Lycke, E.:

Vaccination against rubella of newly delivered women, Scand. J. Infect. Dis.

5: 237-241, 1973.

7 Grillner, L.: Neutralizing antibodies after rubella vaccination of newly delivered women: a comparison between three vaccines, Scand. J. Infect. Dis. 7: 169-172,1975.

8 Wallace, R.B.; Isacson, P.: Comparative trial of HPV-77, DE-5 and RA 27/3 live-attenuated rubella vaccines, Am. J. Dis. Child. 124: 536-538, 1972.

9 Laila, M.; Vesikari, T.; Virolainen, M.: Lymphobiast proliferation and humoral antibody response after rubella vaccination, Clin. Exp. Immunol. 15: 193-202, 1973.

10 LeBouvier, C.L.; Plotkin, 5.A.: Precipitin responses to rubella vaccine RA 27/3, J. Infect. Dis. 123: 220-223, 1971.

11 Horstmann, D.M.: Rubella: The Challenge of its control, J. Infect. Dis. 123: 640-654, 1971.

12

Ogra, P.L.; Kerr-Crant, D.; Umana, G.; Dzierba, J.; Weintraub, D.: Antibody response in serum and nasopharynx after naturally acquired and vaccine-induced infection with rubella virus, N. Engl. J. Med. 285: 1333-1339, 1971.

13

Plotkin, 5.A.; Farquhar, J.D.; Ogra, P.L.: Immunologic properties of RA 27/3 rubella virus vaccine, J. Am. Med. Assoc. 225: 585-590, 1973.

14

Liebhaber, H.; Ingails, T.H.; LeBouvier, G.L.; Horstmann, D.M.: Vaccination with RA 27/3 rubella vaccine. Persistence of immunity and resistance to challenge after two years, Am. J. Dis. Child. 123: 133-136, 1972.

15

Farquhar, J.D.: Follow-up on rubella vaccinations and experience with subclinical reinfection, J. Pediatr. 81: 460-465,1972.

16

Bottiger, M; Christenson, B; Romanus, V; Taranger, J; Strandell, A: Swedish experience of two dose vaccination programme aiming at eliminating measles, mumps, and rubella, Brit. Med. J. 295(14): 1264-1267, November 1987.

17

Markowitz, L E; Preblud, S R; Orenstein, W A; et al; Patterns of transmission in measles outbreaks in the Llnited States, 1985-1986, N. Engl. Med. 320(2): 75-81, January 12, 1989.

18

Peltola, H; Heinonen, 0 P; Valle, M; et al: Five-year experience in elimination of indigenous measles, mumps, and rubella in Finland, Abstracts of the 29th ICAAC, Houston, Texas, Abstract F179, 130, September 1989.

 

19

American Academy of Pediatrics: Report of the Committee on Infectious Disease, Evanston, 111., AAP,p. 136-137, 1982.

20

Recommendation of the Immunisation Practices Advisory Committee (ACIP), Measles Prevention, MMWR 36(26): 409-425, July 10, 1987.

21

Iong, E C, The Travel and Tropical Medicine Manual, W B Sanders Company, p.12-16, 1987.

22

Committee on Immunisation Council of Medical Societies, American College of Physicians, Phila, PA, Guide for Adult Immunisation, First Edition, 1985.

23

Recommendation of the Immunisation Practices Advisory Committee (ACIP), Morbidity and Mortality Weekly Report 33(22): 301-310, 315-318, June 8,

1 984.

24

Mclntosh, R.; Merritt, K.K.; Richards, M.R.; Samuels, M.H.; Bellows, M.T.: The incidence of congenital malformations: A study of 5,964 pregnancies, Pediatr. 14: 505-521, 1954.

25

American Academy of Pediatrics, Committee on Infectious Diseases, Measles: Reassessment of the Current Immunisation Policy, Pediatrics 84(6): 1110-1113, December 1989.

26

Measles Prevention: Recommendations of the

Immunisation Practices Advisory Committee (ACIP), Morbidity and Mortality Weekly Report 38 (5-9): 5-22, December 29, 1989.

27

American Academy of Pediatrics: Report of the Committee on Infectious Disease, Evanston, 111, 1982, p.17.

28

Centre for Disease Control: Immunisation of Children Infected with Human T-Lymphotropic Virus Type III/Lymphadenopathy-Associated Virus, Annals of Internal Medicine, 106: 75-78, 1987.

29

Krasinski, K; Borkowsky, W; Krugman, S: Antibody following measles immunisation in children infected with human T-cell lymphotropic virus-type III/lym phadenopathy associated virus (HTLV-III/EAU) [Abstract]. In: Program and abstracts of the International Conference on Acquired Immunodeficiency Syndrome, Paris, France, June 23-25, 1986.

30

Recommendation of the Immunisation Practices Advisory Committee (ACIP), General Recommendations on Immunisation, Morbidity and Mortality Weekly Report 32(1): 13, January 14, 1983.

31

Starr, 5; Berkovich, S: The effect of measles, gamma globulin modified measles, and attenuated measles vaccine on the course of treated tuberculosis in children, Pediatrics 35(35): 477-481, September 10, 1982.

32 Rubella vaccination during pregnancy – United States,

1971-1981. Morbidity and Mortality Weekly Report

 

31(35): 477-481, September 10, 1982.

33 Recommendation of the Immunisation Practices

Advisory Committee (ACIP), Mumps Vaccine

Morbidity and Mortality Weekly Report 31(46): 617-

620, 625, November 26, 1982.

34 Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Qgra, P.L.; Effect of immunisation against rubella on lactation products. II. Maternal – neonatal interactions, J. Infect. Dis. 145: 661-666, 1982.

35 Landes, R.D.; Bass, J.W.; Mullunchick, E.W.; Oetgen, W.J.: Neonatal rubella following postpartum maternal immunisation, J. Pediatr. 97: 465-467, 1980.

36 Lerman, S.J.: Neonatal rubella following postpartum maternal immunisation, J. Pediatr. 98: 668, 1981. (Letter)

37 CDC, Measles Surveillance, Report No. 11, P. 14,

September 1982.

38 Recommendation of the lmmunisation Practices

Advisory Committee (ACIP), Measles Prevention,

Morbidity and Mortality Weekly Report 31 (17): 217-

224, 229-231, May 7, 1982.

39 Buck, B.E.; Yang, L.C.; Caleb, M.H.; Green, J.M.;

South, M.A.: Measles virus panniculitis subsequent to vaccine administration, J. Pediatrics 101(3): 366-373,1982.

40 Unpublished data from the files of Merck Sharp and

Dohme Research Laboratories.

41 Marks, J S; Halpin, T J: Orenstein, W A: Measles vaccine efficacy in children previously vaccinated at 12 months of age, Pediatrics 62(6): 955-960, December, 1978.

42 National Board of Health and Welfare Code of Statutes, General recommendations on prophylactic immunisation of children, SOFSF (M) 1981:96, November 10, 1981.'

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