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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01444781
Other study ID # A3L27
Secondary ID U1111-1112-8473
Status Completed
Phase Phase 3
First received September 29, 2011
Last updated July 14, 2014
Start date September 2011
Est. completion date October 2013

Study information

Verified date July 2014
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Colombia: National Institutes of HealthCosta Rica: Ministry of Health Costa Rica
Study type Interventional

Clinical Trial Summary

This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are:

- To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose

- To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.

- To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.


Description:

All participants who completed trial A3L24 (NCT01177722) will be recruited to participate in this trial. Those who received DTaP-IPV-Hep B-PRP-T combined vaccine will be randomized to receive either a booster dose of DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.

Those who received Infanrix hexa™ will receive a booster dose of DTaP-IPV-Hep B-PRP-T combined vaccine. All participants will receive a booster dose of Prevenar™ concomitantly.


Recruitment information / eligibility

Status Completed
Enrollment 1106
Est. completion date October 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Months to 24 Months
Eligibility Inclusion Criteria:

- Aged 12 to 24 months on the day of inclusion.

- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness(es) if required by local regulations).

- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.

- Toddlers previously included in Study A3L24 who completed the three-dose primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™ at 2,4 and 6 months of age according to protocol (both concomitantly administered with Prevenar™ and Rotarix™).

Exclusion Criteria:

- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the booster vaccinations.

- Planned participation in another clinical trial during the present trial period.

- Receipt of any vaccine in the 4 weeks preceding the booster vaccinations, except in case of pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.

- Planned receipt of any vaccine in the 4 weeks following the trial vaccinations.

- Previous booster vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s) with either the trial vaccine or another vaccine.

- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.

- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

- Laboratory-confirmed or clinical suspicion of personal or maternal seropositivity for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C, as reported by the parent/guardian.

- History of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s), confirmed either clinically, serologically, or microbiologically.

- At high risk for opportunistic infection during the trial.

- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances.

- History of contraindication to receipt of pertussis-containing vaccine.

- Laboratory-confirmed or clinical suspicion of thrombocytopenia contraindicating Intramuscular vaccination.

- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.

- History of seizures .

- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.

- Receipt of oral or injected antibiotic therapy within 72 hours prior to the first blood draw

- Febrile illness (temperature = 38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide
0.5 mL, Intramuscular each into the right and left deltoid muscle
DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide
0.5 mL, Intramuscular each into the right and left deltoid muscle
DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine
0.5 mL (each), Intramuscular each into the right and left deltoid muscle

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Colombia,  Costa Rica, 

Outcome

Type Measure Description Time frame Safety issue
Primary Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine Anti-Diphtheria (D) antibodies were measured by a toxin neutralization test. Anti-Tetanus (T) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Antibody persistence for anti-Diphtheria and anti-Tetanus antibodies was defined as titers =0.01 IU/mL and =0.1 IU/mL before the booster dose at Day 0. Booster response to Diphtheria and Tetanus was defined as antibody titers =0.01 IU/mL and =0.1 IU/mL at Day 30 post-booster vaccination.
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers
Day 140 (Primary series) and Day 0 (Pre-booster) No
Primary Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine Anti-Pertussis toxin (PT) and anti-Filamentous haemagglutinin (FHA) antibodies were measured by ELISA. Antibody persistence for anti-PT and anti-FHA was defined as titers = lower limit of quantitation (LLOQ) before the booster dose at Day 0. Booster responses for PT and FHA at Day 30 were defined as: pre-vaccination antibody concentrations < LLOQ and post-vaccination levels = 4 x LLOQ, pre-vaccination antibody concentrations = LLOQ but < 4 x LLOQ and post/pre vaccination = 4, and pre-vaccination antibody concentrations = 4 x LLOQ and post/pre-vaccination = 2.
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination No
Primary Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Antibody persistence for anti-Poliovirus 1, 2, and 3 was defined as antibody titers =8 (1/dil) before the booster dose at Day 0. Booster response to Poliovirus 1, 2, and 3 was defined as antibody titers =8 (1/dil) at Day 30.
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination No
Primary Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate (PRP) antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Anti-Hepatitis antibody titers = 10 mIU/mL and = 100 mIU/mL at Day 0 confirmed antibody persistence and booster response at Day 30. Anti-PRP antibody titers = 0.15 µg/ml and = 1.0 µg/ml at Day 0 confirmed antibody persistence and booster response at Day 30.
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination No
Secondary Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine. Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus, anti-PT, and anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay. Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-PRP antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker).
Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers.
Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination No
Secondary Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA. Booster response to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F was defined as antibody titers =0.35 µg/mL at Day 30. Day 30 after final booster vaccination No
Secondary Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA. Day 30 after final booster vaccination No
Secondary Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata Anti-PT and anti-FHA antibodies were measured by ELISA. Day 0 (pre-vaccination) and Day 30 after final booster vaccination No
Secondary Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay. Day 30 after final booster vaccination No
Secondary Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb; Solicited systemic reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 Injection site: Pain, Cries if limb is moved or reduced movement; Erythema and Swelling, =5 cm; Extensive swelling of limb, Severe. Grade 3 Systemic reactions: Pyrexia (Temperature) >39.5°C; Vomiting, = 6 times per 24 hours or needing parenteral nutrition; Crying, >3 hours; Somnolence, Sleeping often or difficulty waking; Anorexia, refuses =3 meals; and Irritability, Inconsolable. Day 0 up to Day 7 after final booster vaccination No
Secondary Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Grade 3 Injection site: Pain, cries if limb is moved or reduced movement; Erythema and Swelling, =5 cm; and Extensive swelling of limb, Severe. Day 0 up to Day 7 after final booster vaccination No
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