PMID- 9849978
OWN - NLM
STAT- MEDLINE
DCOM- 19990202
LR  - 20190818
IS  - 0891-3668 (Print)
IS  - 0891-3668 (Linking)
VI  - 17
IP  - 11
DP  - 1998 Nov
TI  - Safety, tolerability and immunogenicity of concomitant injections in separate 
      locations of M-M-R II, VARIVAX and TETRAMUNE in healthy children vs. concomitant 
      injections of M-M-R II and TETRAMUNE followed six weeks later by VARIVAX.
PG  - 980-5
AB  - OBJECTIVES AND STUDY DESIGN: The primary objectives of this study were to compare 
      immunologic responses, antibody persistence, safety and varicella breakthrough 
      rates when VARIVAX (varicella vaccine) is given at the same time as M-M-R II 
      (measles, mumps, rubella vaccine) and TETRAMUNE (conjugate Haemophilus influenzae 
      type b, diphtheria, tetanus and whole cell pertussis vaccine) at separate 
      injection sites (Group A) vs. VARIVAX given 6 weeks after M-M-R II and TETRAMUNE 
      (Group B). Six hundred nine healthy children, 12 to 23 months of age, were 
      randomized to one of two treatment (immunization) groups (Group A and Group B). 
      Blood for antibody titers was drawn on the day of immunization, 6 weeks after 
      each injection and 1 year later. Local and systemic adverse reactions were 
      recorded. Exposure and cases of varicella were documented through a 1-year 
      follow-up period. RESULTS: Measles, mumps and rubella seroconversion rates and 
      geometric mean titers (GMTs) were similar for both treatment groups. Varicella 
      seroconversion rates were also similar between groups. However, varicella GMTs 
      and percent with a varicella-protective level [> or =5.0 glycoprotein (gp) 
      enzyme-linked immunosorbent assay (ELISA) units] did not meet the prespecified 
      criteria for similarity were lower for Group A (GMT 10.5; 82.8% > or =5.0 gp 
      ELISA units) than for Group B (GMT 14.5; 91.2% > or =5.0 gp ELISA units). The 
      GMTs between groups for other antibodies were similar. At the 1-year follow-up 
      antibody titers were comparable in both groups and breakthrough varicella cases 
      appeared generally similar. There were fewer local adverse events (AEs) at the 
      VARIVAX injection sites (9.8% and 2.9%, Group A and B, respectively) than at the 
      TETRAMUNE sites (27.9% and 24.0%). Systemic AEs were not statistically different 
      when M-M-R II was administered alone (8.6%) or concomitantly with VARIVAX (8.9%). 
      When VARIVAX was given alone AEs were 1.8%. The rate of fever > or =102 degrees F 
      after M-M-R II and TETRAMUNE administered together was 10.7% on Days 0 to 3 and 
      23.7% on Days 7 to 21. When VARIVAX was administered alone, the rate of fever was 
      5.4% on Days 0 to 3 (P = 0.018) and 10.8% on Days 7 to 21 (P<0.001). CONCLUSION: 
      Because the varicella titers were comparable and varicella breakthrough rates 
      generally similar at 1 year in both groups, we expect that the concomitant 
      administration of VARIVAX with M-M-R II and TETRAMUNE has clinical effectiveness 
      similar to that with VARIVAX 6 weeks after the administration of these other two 
      vaccines. VARIVAX appears to be less reactogenic than M-M-R II and TETRAMUNE.
FAU - Shinefield, H R
AU  - Shinefield HR
AD  - Kaiser Permanente Vaccine Study Center, Oakland, CA 94115, USA. 
      henry.shinefield@ncal.kaiperm.org
FAU - Black, S B
AU  - Black SB
FAU - Staehle, B O
AU  - Staehle BO
FAU - Adelman, T
AU  - Adelman T
FAU - Ensor, K
AU  - Ensor K
FAU - Ngai, A
AU  - Ngai A
FAU - White, C J
AU  - White CJ
FAU - Bird, S R
AU  - Bird SR
FAU - Matthews, H
AU  - Matthews H
FAU - Kuter, B J
AU  - Kuter BJ
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Chickenpox Vaccine)
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Measles Vaccine)
RN  - 0 (Measles-Mumps-Rubella Vaccine)
RN  - 0 (Mumps Vaccine)
RN  - 0 (Rubella Vaccine)
RN  - 0 (Vaccines, Combined)
RN  - 0 (Vaccines, Conjugate)
RN  - 0 (diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine)
SB  - IM
MH  - Antibodies, Bacterial/analysis
MH  - Antibodies, Viral/analysis
MH  - Chickenpox Vaccine/administration & dosage/*immunology
MH  - Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage/*immunology
MH  - Haemophilus Vaccines/administration & dosage/*immunology
MH  - Humans
MH  - Immunization Schedule
MH  - Infant
MH  - Measles Vaccine/administration & dosage/*immunology
MH  - Measles-Mumps-Rubella Vaccine
MH  - Mumps Vaccine/administration & dosage/*immunology
MH  - Rubella Vaccine/administration & dosage/*immunology
MH  - Vaccines, Combined/administration & dosage/immunology
MH  - Vaccines, Conjugate/administration & dosage/*immunology
EDAT- 1998/12/16 00:00
MHDA- 1998/12/16 00:01
CRDT- 1998/12/16 00:00
PHST- 1998/12/16 00:00 [pubmed]
PHST- 1998/12/16 00:01 [medline]
PHST- 1998/12/16 00:00 [entrez]
AID - 10.1097/00006454-199811000-00003 [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 1998 Nov;17(11):980-5. doi: 
      10.1097/00006454-199811000-00003.