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
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ClinicalTrials.gov Identifier: NCT02610348 |
Recruitment Status :
Completed
First Posted : November 20, 2015
Last Update Posted : March 20, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis B | Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 122 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Persistence of Anti-Hep B Antibodies at 12 to 18 Months of Age in Children Having Received Hep B Vaccine at Birth and a DTaP-IPV-HB-Hib Hexavalent Vaccine (Hexaxim® or Infanrix Hexa®) Concomitantly With Prevnar® at 2, 4 and 6 Months of Age |
Study Start Date : | November 2015 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | March 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Group A
Toddlers vaccinated with Hexaxim®/Hexyon®/Hexacima® in study A3L12
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Biological: 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 |
Experimental: Group B
Toddlers vaccinated with Infanrix hexa® in study A3L12
|
Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study |
- Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study [ Time Frame: Day 0 ]Levels of anti-Hepatitis B antibody concentrations will be determined at ≥ 10 mIU/mL and ≥ 100 mIU/mL

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Ages Eligible for Study: | 12 Months to 18 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
Exclusion Criteria:
- Not applicable.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610348
Thailand | |
Bangkok, Thailand, 10700 | |
Khon Kaen, Thailand, 40002 |
Study Director: | Medical Director | Sanofi Pasteur SA |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT02610348 |
Other Study ID Numbers: |
A3L47 U1111-1161-2649 ( Other Identifier: WHO ) |
First Posted: | November 20, 2015 Key Record Dates |
Last Update Posted: | March 20, 2018 |
Last Verified: | March 2018 |
Hepatitis B Hexaxim® Hexyon® |
Hexacima® Prevnar® DTaP-IPV-HB-Hib hexavalent vaccine |
Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Hepadnaviridae Infections DNA Virus Infections Vaccines Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |