Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination

• Register: EUCTR
• Last refreshed on: 25 April 2016
• Main ID: EUCTR2011-004451-39-Outside-EU/EEA
• Date of registration: 19/04/2016
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur Inc.
• Public title: Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination
• Scientific title: Evaluation of Antibody Persistence at 3.5 and 4.5 Years of Age in Healthy Children After Primary Series and Booster Vaccination with Investigational (DTaP-IPV-HB-Hib) or Infanrix™ hexa vaccines in Latin America
• Target sample size: 699
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004451-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Infanrix™ Hexa Number of treatment arms in the trial: 2

Countries of recruitment

Colombia, Costa Rica

Contacts

• Name: Central Clinical Team Leader
• Affiliation: Sanofi Pasteur Inc.

• Name: Central Clinical Team Leader
• Affiliation: Sanofi Pasteur Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
A potential subject had to meet all of the following criteria to be considered for trial
enrollment:
1) Aged 3 years and a half (42 months ± 60 days) on the day of the first study visit
2) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness/es if required by local regulations)
3) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
4) Receipt of primary vaccination with 3 doses of investigational vaccines during the primary series trial A3L24 (either DTaP-IPV-HB-Hib or Infanrix™ hexa, concomitantly administered with Prevenar™ [PCV7] and Rotarix™) and a booster dose during the trial A3L27 (either DTaP-IPV-HB-Hib
Are the trial subjects under 18? yes
Number of subjects for this age range: 558
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
A potential subject meeting any of the following criteria was ineligible for trial enrollment:
1) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial visit) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
2) Incomplete primary and booster immunization at trial A3L24 and A3L27
3) Receipt of any vaccine in the 4 weeks preceding the first trial visit or planned receipt of any vaccine in the 4 weeks preceding the second trial visit
4) Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections with other vaccine(s) after completion of A3L27 study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis, Haemophilius Influenzae Type b

Intervention(s)

Product Name: DTaP-IPV-Hep B-PRP~T combined vaccine
Pharmaceutical Form: Suspension for injection

Trade Name: Infanrix™ hexa
Product Name: Infanr?ix™ Hexa
Pharmaceutical Form: Suspension for injection

Trade Name: Prevenar
Product Name: Prevenar
Product Code: PCV7
Pharmaceutical Form: Suspension for injection in pre-filled syringe

Primary Outcome(s)

Main Objective: To describe the long-term antibody (Ab) persistence at 3.5 and 4.5 years of age following a 3-dose primary series vaccination of either DTaP-IPV-HB-Hib+Prevenar™ (PCV7)+Rotarix™ or Infanrix™ hexa+Prevenar™ (PCV7)+Rotarix™ vaccination at 2, 4, 6 months of age and a booster vaccination of DTaP-IPV-HB-Hib+Prevenar™ (PCV7) or Infanrix™ hexa+Prevenar™ (PCV7) at 12 to 24 months of age. Only 2 doses of
Rotarix™ were administered in the primary series at 2 and 4 months of age.

Primary end point(s): The following serological endpoints were assessed in children aged 3.5 years (months [M]18 to M30 post-booster dose) and 4.5 years of age (M30 to M42 post-booster dose) according to the groups assigned in A3L27 study:
- Ab concentrations/titers for each valence (except PCV7 and Rotarix™ valences)
- Ab concentrations/titers above a cut-off:
- Anti-D Ab concentrations = 0.01 IU/mL, = 0.1 IU/mL and = 1.0 IU/mL
- Anti-T Ab concentrations = 0.01 IU/mL, = 0.1 IU/mL and = 1.0 IU/mL
- Anti-Hep B Ab concentrations = 10 mIU/mL and = 100 mIU/mL
- Anti-PRP Ab concentrations = 0.15 µg/mL and = 1.0 µg/mL
- Anti-pertussis toxin (PT) and anti-filamentous hemagglutinin (FHA) Ab concentrations = LLOQ* (Lower Limit of Quantitation), = 2x LLOQ and
= 4x LLOQ
- Anti-poliovirus 1, 2, and 3 Ab titers = 8 (1/dil)

(* LLOQ = 2 enzyme-linked immunosorbent assay [ELISA] units [EU]/mL for PT and FHA)

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: 3.5 years (Month 18 to Month 30 post-booster dose) and 4.5 years (Month 30 to Month 42 post-booster dose)

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

A3L28

NCT01983540

Source(s) of Monetary Support

Sanofi Pasteur Inc.