Immunologic non-inferiority and safety of the investigational pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) 4-dose vial presentation compared to the licensed PHiD-CV 1-dose vial presentation in infants: A phase III randomized study

To support vaccination programs in developing countries, a 4-dose vial presentation of pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) was developed. This study assessed immunologic non-inferiority and safety of the investigational PHiD-CV 4-dose versus license...

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Bibliographic Details
Published in:Vaccine 2018-01, Vol.36 (5), p.698-706
Main Authors: Zaman, Khalequ, Zaman, Sheikh Farzana, Zaman, Farzana, Aziz, Asma, Faisal, Sayeed-Bin, Traskine, Magali, Habib, Md Ahsan, Ruiz-Guiñazú, Javier, Borys, Dorota
Format: Article
Language:English
Subjects:
1-dose vial presentation
4-dose vial presentation
Babies
Clinical trials
Confidence intervals
Developing countries
Dosage
Enzymes
Haemophilus influenzae
Immune response
Immunization
Immunologic non-inferiority
Infants
Laboratories
LDCs
Licenses
Measles
Objectives
Pediatrics
Pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV)
Preservatives
Protein D
Proteins
Public health
Randomization
Rubella
Safety
Streptococcus infections
Tetanus
Vaccines
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Summary:To support vaccination programs in developing countries, a 4-dose vial presentation of pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) was developed. This study assessed immunologic non-inferiority and safety of the investigational PHiD-CV 4-dose versus licensed 1-dose vial presentation in infants. In this phase III, mono-center, observer-blind study in Bangladesh, 6–10-week-old infants were randomized 1:1 to receive PHiD-CV primary vaccination (at ages 6, 10, 18 weeks) and a booster dose (at age 9 months) with a 4-dose vial (with preservative, 4DV group) or 1-dose vial (preservative-free, 1DV group). DTPw-HBV/Hib was (co)-administered per study protocol and polio, measles and rubella vaccines as part of the national immunization program. Non-inferiority of PHiD-CV 4-dose versus 1-dose vial for each vaccine pneumococcal serotype (VT) and vaccine-related serotype 19A in terms of antibody geometric mean concentration (GMC) was assessed (criterion: upper limit of 2-sided 95% confidence interval of antibody GMC ratios [1DV/4DV]
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2017.12.034