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Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV

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ClinicalTrials.gov Identifier: NCT00362336
Recruitment Status : Completed
First Posted : August 10, 2006
Results First Posted : May 2, 2014
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Hepatitis B
Polio
Diphtheria
Pertussis
Haemophilus Influenzae Type b
Interventions: Biological: DTaP-IPV-HB-PRP~T
Biological: CombAct-HIB®
Biological: Engerix B® Pediatric

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 28 August 2006 to 11 February 2007 in 2 clinical centers in South Africa.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 622 of the 715 recruited participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
DTaP-IPV-Hep B-PRP~T Group Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
CombAct-Hib™ + Engerix B™ + OPV Group Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.

Participant Flow:   Overall Study
    DTaP-IPV-Hep B-PRP~T Group   CombAct-Hib™ + Engerix B™ + OPV Group   DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group
STARTED   243   242   137 
COMPLETED   233   235   134 
NOT COMPLETED   10   7   3 
Serious Adverse Event                1                0                1 
Protocol Violation                0                0                1 
Lost to Follow-up                6                4                0 
Withdrawal by Subject                3                3                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DTaP-IPV-Hep B-PRP~T Group Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
CombAct-Hib™ + Engerix B™ + OPV Group Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
Total Total of all reporting groups

Baseline Measures
   DTaP-IPV-Hep B-PRP~T Group   CombAct-Hib™ + Engerix B™ + OPV Group   DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 243   242   137   622 
Age 
[Units: Participants]
       
<=18 years   243   242   137   622 
Between 18 and 65 years   0   0   0   0 
>=65 years   0   0   0   0 
Age 
[Units: Days]
Mean (Standard Deviation)
 1.04  (0.729)   1.07  (0.762)   1.11  (0.773)   1.07  (0.751) 
Gender 
[Units: Participants]
       
Female   131   118   68   317 
Male   112   124   69   305 
Region of Enrollment 
[Units: Participants]
       
South Africa   243   242   137   622 


  Outcome Measures

1.  Primary:   Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)   [ Time Frame: 1 month post-Dose 3 ]

2.  Secondary:   Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)   [ Time Frame: 1 month post-Dose 3 ]

3.  Secondary:   Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)   [ Time Frame: Day 42 before Dose 1 and 1 month post-Dose 3 ]

4.  Secondary:   Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV   [ Time Frame: Day 540 pre-booster and Day 570 post-booster ]

5.  Secondary:   Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV   [ Time Frame: Day 540 pre-booster and Day 570, post-booster ]

6.  Secondary:   Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV).   [ Time Frame: Day 0 up to Day 7 post each dose ]

7.  Secondary:   Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)   [ Time Frame: Day 0 up to 7 post-booster vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com


Publications of Results:

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00362336     History of Changes
Other Study ID Numbers: A3L15
First Submitted: August 8, 2006
First Posted: August 10, 2006
Results First Submitted: February 14, 2014
Results First Posted: May 2, 2014
Last Update Posted: May 2, 2014