Anti-Hep B Antibodies at Age 12 to 18 Months After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine Concomitantly With Prevnar® at 2, 4 and 6 Months of Age

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Primary Objective:

To describe the persistence of Hep B antibodies (Ab) at 12 to 18 months of age following a three-dose infant primary series vaccination of either Hexaxim®/Hexyon®/Hexacima® or Infanrix® hexa at 2, 4 and 6 months of age following Hep B vaccination at birth.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.

NCT02697474

Hepatitis B

COMPLETED PHASE3

Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants

NCT00401531

Hepatitis B Polio Diphtheria +2 more

COMPLETED PHASE3

Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth

NCT01948193

Diphtheria Tetanus Whooping Cough +3 more

COMPLETED PHASE3

Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™

NCT01358825

Tetanus Poliomyelitis Haemophilus Influenzae Type b +4 more

COMPLETED PHASE4

To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines

NCT00366366

Hepatitis B

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Sera from subjects who have participated in study PNA19 trial (NCT00594347) and for whom parents or legal representatives had given authorization to use the sera taken from their child will be used for this study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis B

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Toddlers vaccinated with Hexaxim®/Hexyon®/Hexacima® in study A3L12

Group Type EXPERIMENTAL

DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines

Intervention Type BIOLOGICAL

Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study

Group B

Toddlers vaccinated with Infanrix hexa® in study A3L12

Group Type EXPERIMENTAL

DTaP-HB-IPV and Pneumococcal polysaccharide vaccines

Intervention Type BIOLOGICAL

Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines

Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study

Intervention Type BIOLOGICAL

DTaP-HB-IPV and Pneumococcal polysaccharide vaccines

Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects having received 4 Hep B doses in A3L12 (i.e. one dose at birth + three doses during study at 2, 4 \& 6 months of age)
* Subjects having participated in PNA19
* Subject's parents having given authorization to use serum collected in PNA19 for future research
* The initials, birth date, and gender of the subject are consistent between A3L12 and PNA19 databases
* Subjects for whom retention sera are of enough volume to allow a valid determination of the HBsAg antibody level.