PMID- 22173143
OWN - NLM
STAT- MEDLINE
DCOM- 20120511
LR  - 20131121
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Linking)
VI  - 31
IP  - 2
DP  - 2012 Feb
TI  - Safety and immunogenicity of 2 mixed primary infant immunization schedules of 
      pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, 
      and Haemophilus influenzae Type B vaccines at 2, 4, and 6 months of age: a 
      randomized controlled trial.
PG  - 189-92
LID - 10.1097/INF.0b013e318242462a [doi]
AB  - BACKGROUND: Two pentavalent infant vaccines that contain either 5 or 3 component 
      acellular pertussis antigens are authorized in Canada. Because of changes in 
      vaccine use by provinces over time and movement of families across jurisdictions, 
      it is possible that children are exposed to different combination vaccines during 
      the primary infant immunization schedule. The safety and immunogenicity of mixed 
      primary infant schedules is unknown. METHODS: In a double-blind multicenter 
      trial, 2-month-old healthy infants were randomized to 1 of 2 schedules at 2, 4, 
      and 6 months of age (either Pediacel, Pediacel, Infanrix [PPI] or Infanrix, 
      Pediacel, Pediacel [IPP]). Solicited local and systemic adverse events (AEs) were 
      collected by parent diary on days 0 through 7; unsolicited AEs were collected for 
      31 days after each dose. Immune responses to polypolyribosylribitol phosphate 
      capsular polysaccharide (PRP) (Haemophilus influenzae type b) and pertussis 
      antigens were assessed before the first dose and 28 days after the 6 month 
      (third) dose. RESULTS: In all, 127 infants were randomized to IPP and 126 to PPI. 
      The percentage of children with anti-PRP responses >/=0.15 mug/mL after dose 3 was 
      higher in the IPP than in the PPI group (98.3, 95% CI: 94.1, 99.8 vs. 86.1%, 95% 
      CI: 78.6, 91.7, P < 0.001). Antipertussis toxin and anti-fimbriae 2 and 3 
      responses were statistically significantly higher in the IPP than in the PPI 
      group. Higher filamentous hemagglutinin responses occurred in PPI than in IPP. No 
      difference between groups was observed in pertactin responses.Systemic AEs were 
      similar between the 2 vaccine schedules. Irritability (67.2 vs. 51.6, P = 0.014) 
      and mild crying (35.2% vs. 23.0%, P = 0.037) were more common after the 6-month 
      dose in the PPI compared with the IPP group, as were overall systemic reactions 
      (any intensity) for the PPI group after this dose (80.0 vs. 68.0, P = 0.042). 
      CONCLUSION: Mixed 2-, 4-, 6-month pentavalent infant vaccine schedules had 
      different immunogenicity and reactogenicity, with a PPI schedule being more 
      reactogenic, and less immunogenic for PRP and fimbriae 2 and 3 antigens at 7 
      months. It is preferable to complete the primary infant 3-dose vaccine series 
      with the same vaccine, rather than considering infant vaccines as 
      interchangeable.
FAU - Langley, Joanne M
AU  - Langley JM
AD  - Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre and 
      Capital Health, Halifax, Canada. jmlangle@dal.ca
FAU - Halperin, Scott A
AU  - Halperin SA
FAU - Rubin, Earl
AU  - Rubin E
FAU - White, Craig
AU  - White C
FAU - McNeil, Shelly
AU  - McNeil S
FAU - Mutch, Jill
AU  - Mutch J
FAU - Mackinnon-Cameron, Donna
AU  - Mackinnon-Cameron D
FAU - Smith, Bruce
AU  - Smith B
LA  - eng
SI  - ClinicalTrials.gov/NCT00990080
PT  - Journal Article
PT  - Multicenter Study
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 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Vaccines, Conjugate)
RN  - 0 (diphtheria-tetanus-five component acellular pertussis-inactivated 
      poliomyelitis -Haemophilus influenzae type b conjugate vaccine)
SB  - IM
MH  - Antibodies, Bacterial/blood
MH  - Canada
MH  - Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage/*adverse 
      effects/*immunology
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - Haemophilus Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Humans
MH  - *Immunization Schedule
MH  - Incidence
MH  - Infant
MH  - Infant, Newborn
MH  - Male
MH  - Poliovirus Vaccine, Inactivated/administration & dosage/*adverse 
      effects/*immunology
MH  - Vaccines, Conjugate/administration & dosage/adverse effects/immunology
EDAT- 2011/12/17 06:00
MHDA- 2012/05/12 06:00
CRDT- 2011/12/17 06:00
PHST- 2011/12/17 06:00 [entrez]
PHST- 2011/12/17 06:00 [pubmed]
PHST- 2012/05/12 06:00 [medline]
AID - 10.1097/INF.0b013e318242462a [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2012 Feb;31(2):189-92. doi: 10.1097/INF.0b013e318242462a.