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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
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

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

Detailed Description:
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.

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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
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




Primary Outcome Measures :
  1. 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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Thailand
Bangkok, Thailand, 10700
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur SA

Publications of Results:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02610348     History of Changes
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
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Hepatitis B
Hexaxim®
Hexyon®
Hexacima®
Prevnar®
DTaP-IPV-HB-Hib hexavalent vaccine
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Antibodies
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs