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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610348
• Other study ID #: A3L47
• Secondary ID: U1111-1161-2649
• Status: Completed
• Phase: N/A
• First received: November 18, 2015
• Last updated: March 19, 2018
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2018
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 18 Months

Eligibility

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:

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

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
• DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Kosalaraksa P, Chokephaibulkit K, Benjaponpitak S, Pancharoen C, Chuenkitmongkol S, B'Chir S, Da Costa X, Vidor E. Persistence of hepatitis B immune memory until 9-10 years of age following hepatitis B vaccination at birth and DTaP-IPV-HB-PRP~T vaccinatio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study	Levels of anti-Hepatitis B antibody concentrations will be determined at = 10 mIU/mL and = 100 mIU/mL	Day 0