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Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00325156
First received: February 8, 2006
Last updated: December 14, 2016
Last verified: November 2016
Results First Received: December 14, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Diphtheria
Tetanus
Poliomyelitis
Acellular Pertussis
Haemophilus Influenzae Type b
Intervention: Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Reporting Groups
  Description
Infanrix-IPV+Hib Group Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.

Participant Flow:   Overall Study
    Infanrix-IPV+Hib Group
STARTED   2590 
COMPLETED   2478 
NOT COMPLETED   112 
Protocol Violation                8 
Lost to follow-up (complete vaccination)                41 
Migrated/moved from study area                12 
Adverse event, non-fatal                3 
Lost to follow-up (incompl. vaccination)                16 
Unspecified                1 
Withdrawal by Subject                31 



  Baseline Characteristics
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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
Infanrix-IPV+ Hib Group Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.

Baseline Measures
   Infanrix-IPV+ Hib Group 
Overall Participants Analyzed 
[Units: Participants]
 2590 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 13.3  (0.87) 
Gender 
[Units: Participants]
Count of Participants
 
Female      1245  48.1% 
Male      1345  51.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Reporting Any Solicited Local and General Symptoms   [ Time Frame: During the 4-day (Days 0-3) post-vaccination period, across doses ]

2.  Secondary:   Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)   [ Time Frame: During the 30-day (Days 0-29) post-vaccination period ]

3.  Secondary:   Number of Subjects Reporting Large Injection Site Swelling   [ Time Frame: At Month 18, post-booster dose ]

4.  Secondary:   Number of Subjects Reporting Any Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
None reported.


  More Information
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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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00325156     History of Changes
Other Study ID Numbers: 100917
Study First Received: February 8, 2006
Results First Received: December 14, 2016
Last Updated: December 14, 2016