PMID- 23783081
OWN - NLM
STAT- MEDLINE
DCOM- 20140729
LR  - 20211021
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 9
IP  - 9
DP  - 2013 Sep
TI  - A phase III single arm, multicenter, open-label study to assess the 
      immunogenicity and tolerability of a pentavalent DTwP-HepB-Hib vaccine in indian 
      infants.
PG  - 1903-9
LID - 10.4161/hv.25166 [doi]
AB  - Compliance with recommended vaccinations for Indian infants is facilitated by 
      using combination vaccines to minimize the number of required injections. The 
      ready-to-use, preservative free, fully-liquid combination DTwP-HepB-Hib vaccine, 
      Quinvaxem((R)), offers convenience of administering five important vaccine antigens 
      to infants in a single injection. This phase III, single-arm, multicenter study 
      was designed to assess immunogenicity and safety of three doses of Quinvaxem((R)) 
      to Indian infants administered at 6, 10, and 14 weeks of age. Blood samples were 
      taken prior to the first dose and at one month post last vaccination. Infants 
      were observed clinically for any reaction approximately 30 min following each 
      vaccination, and parents completed subject diaries for solicited local, systemic 
      and any adverse events (AEs) following over a 5 d period. DTwP-HepB-Hib vaccine 
      elicited strong immune responses that exceeded seroprotection/seroconversion 
      thresholds against all vaccine antigens. At one month after third vaccination, 
      percentages of infants achieving predefined protective antibody levels were 99% 
      diphtheria; 100% tetanus; 98% Hepatitis B; 100% Hib short-term (>/= 0.15 microg/mL); 
      95% Hib long-term (>/= 1.0 microg/mL) protection; and relevant immune response was 99% 
      for pertussis. The vaccine was well tolerated, with no vaccine-related serious 
      AEs. Only one case of high fever (>/= 40  degrees C) was reported. The most frequently 
      reported reactions were mild to moderate tenderness and erythema. Frequencies of 
      all AEs declined with subsequent vaccinations. This study demonstrated that this 
      convenient, fully-liquid DTwP-HepB-Hib vaccine is highly immunogenic and has a 
      acceptable safety profile for use in Indian infants. ClinicalTrials.gov 
      Identifier: NCT01470287. Clinical Trials Registry of India Number: 
      CTRI/2011/11/002118.
FAU - Eregowda, Adarsh
AU  - Eregowda A
AD  - Rajarajeshwari Medical College & Hospital; Bangalore, India.
FAU - Lalwani, Sanjay
AU  - Lalwani S
FAU - Chatterjee, Sukanta
AU  - Chatterjee S
FAU - Vakil, Hoshang
AU  - Vakil H
FAU - Ahmed, Khaleel
AU  - Ahmed K
FAU - Costantini, Marco
AU  - Costantini M
FAU - Lattanzi, Maria
AU  - Lattanzi M
LA  - eng
SI  - ClinicalTrials.gov/NCT01470287
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130619
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (DtwP-HepB-Hib vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Hepatitis B Antibodies)
RN  - 0 (Hepatitis B Vaccines)
SB  - IM
MH  - Antibodies, Bacterial/*blood
MH  - Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage/*adverse 
      effects/*immunology
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Erythema/chemically induced/epidemiology
MH  - Female
MH  - Fever/chemically induced/epidemiology
MH  - Haemophilus Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Hepatitis B Antibodies/*blood
MH  - Hepatitis B Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Humans
MH  - India
MH  - Infant
MH  - Male
MH  - Vaccination/*adverse effects/*methods
PMC - PMC3906354
OTO - NOTNLM
OT  - DTwP-HepB-Hib
OT  - Immunogenicity
OT  - Safety
OT  - combination vaccine
OT  - fully-liquid pentavalent vaccine
OT  - infants
EDAT- 2013/06/21 06:00
MHDA- 2014/07/30 06:00
PMCR- 2014/09/01
CRDT- 2013/06/21 06:00
PHST- 2013/06/21 06:00 [entrez]
PHST- 2013/06/21 06:00 [pubmed]
PHST- 2014/07/30 06:00 [medline]
PHST- 2014/09/01 00:00 [pmc-release]
AID - 25166 [pii]
AID - 2013HV0096R [pii]
AID - 10.4161/hv.25166 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2013 Sep;9(9):1903-9. doi: 10.4161/hv.25166. Epub 2013 Jun 
      19.