Abstract | BACKGROUND: METHODS: Healthy Gambian infants were randomized at the age of 2 months to receive three doses 1 month apart of either (1) placebo reconstituted in TETRAMUNE in the right thigh (control) or (2) PnCV in the left thigh and TETRAMUNE in the right thigh (separate) or (3) PnCV reconstituted in TETRAMUNE as a single injection in the right thigh (combined). The vaccines were given together with routine Expanded Program on Immunization vaccines. Adverse reactions were recorded after vaccination, and antibody concentrations were measured by enzyme-linked immunosorbent assays. RESULTS: Local induration and tenderness were observed more commonly at the site of injection of TETRAMUNE than at the site of injection with PnCV after each dose of vaccination. Swelling at the site of injection was encountered more frequently at the site of administration of TETRAMUNE than at the site of administration PnCV ( P< 0.00001 for Doses 1 and 2 and P< 0.0009 for Dose 3). Swelling at the site of administration of TETRAMUNE mixed with PnCV was comparable with that observed for TETRAMUNE alone. Although most mothers reported that the babies "felt hot" 24 h after each injection, febrile reactions (temperature, >or=38 degrees C) were infrequent and resolved with antipyretics. Geometric mean titer for anti-polyribosylribitol phosphate antibody was 11.6 microg/ml [95% confidence limits (95% CI), 9.2, 14.6] in the control group and comparable with 13.3 microg/ml (95% CI 11.0, 16.0) in the combined group and significantly higher at 17.9 microg/ml (95% CI 14.7, 21.9; P= 0.01) in the separate group. Geometric mean concentrations of serotype-specific pneumococcal antibodies were higher in the combined group than the separate group for all nine serotypes. Antibody responses to diphtheria and pertussis antigens were similar in all groups. Anti- tetanus toxoid antibody concentrations were lowest in the combined group (6.66 IU/ml, 95% CI 5.77, 7.68 in the control group; 5.15 IU/ml, 95% CI 4.39, 6.03 in the combined group; P= 0.02). However, all vaccinees achieved protective antibody values. CONCLUSION: The combination of TETRAMUNE and PnCV is safe and immunogenic.
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Authors | Stephen K Obaro, Godwin C Enwere, Maria Deloria, Shabbar Jaffar, David Goldblatt, Kate Brainsby, Hans Hallander, Pamela McInnes, Brian M Greenwood, Keith P W J McAdam |
Journal | The Pediatric infectious disease journal
(Pediatr Infect Dis J)
Vol. 21
Issue 10
Pg. 940-7
(Oct 2002)
ISSN: 0891-3668 [Print] United States |
PMID | 12394817
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Diphtheria-Tetanus-Pertussis Vaccine
- Haemophilus Vaccines
- Haemophilus influenzae type b polysaccharide vaccine
- Polysaccharides, Bacterial
- Vaccines, Combined
- Vaccines, Conjugate
- diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine
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Topics |
- Bacterial Capsules
- Confidence Intervals
- Developing Countries
- Diphtheria-Tetanus-Pertussis Vaccine
(administration & dosage)
- Female
- Gambia
- Haemophilus Vaccines
(administration & dosage)
- Humans
- Immunity
(physiology)
- Immunization Programs
(organization & administration)
- Immunization Schedule
- Infant
- Male
- Polysaccharides, Bacterial
(administration & dosage)
- Probability
- Reference Values
- Safety
- Vaccination
(methods)
- Vaccines, Combined
(administration & dosage)
- Vaccines, Conjugate
(administration & dosage)
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