Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age

A Phase-III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine (DTwP-Hib-HepB Vaccine) When Administered to Indian Infants at 6, 10, and 14 Weeks of Age

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01470287

Enrollment

175

Registered

2011-11-11

Start date

2011-12-31

Completion date

2012-04-30

Last updated

2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diphtheria, Hemophilus Influenzae B, Hepatitis B, Pertussis, Tetanus

Keywords

Infants,, Immunogenicity,, Safety

Brief summary

This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.

Interventions

BIOLOGICALDTwP-HepB-Hib Vaccine

Open label, Single arm study to evaluate immunogenicity, safety and tolerability of a fully liquid pentavalent (DTwP-HepB-Hib) vaccine in infants of 6-8 weeks of age.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

42 Days to 64 Days

Healthy volunteers

Yes

Inclusion criteria

1. Male and female subjects ≥ 42 days to ≤ 64 days of age. 2. Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements

Exclusion criteria

1. Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study. 2. History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine. 3. History of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component. 4. Administration of parenteral immunoglobulin preparation and/or blood products since birth.

Design outcomes

Primary

Measure	Time frame
Seroprotection rate one month after the last dose of vaccine administration	One month after last vaccination

Secondary

Measure	Time frame
Seroprotection rate and GMCs one month after the last vaccine administration	One month after last vaccination

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026