Trial record 1 of 2 for:
Tetravac phase 3
Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.
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ClinicalTrials.gov Identifier: NCT00871000 |
Recruitment Status :
Completed
First Posted : March 30, 2009
Results First Posted : April 18, 2017
Last Update Posted : June 6, 2018
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Acellular Pertussis Tetanus Diphtheria Poliomyelitis |
Interventions |
Biological: Boostrix Polio™ 711866 Biological: Priorix Tetra TM 208136 Biological: Tetravac TM |
Enrollment | 303 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. |
Arm/Group Title | Boostrix Polio Group | Tetravac Group |
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Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm. |
Period Title: Overall Study | ||
Started | 151 | 152 |
Completed | 150 | 152 |
Not Completed | 1 | 0 |
Reason Not Completed | ||
Withdrawal by Subject | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Boostrix Polio Group | Tetravac Group | Total | |
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Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | Total of all reporting groups | |
Overall Number of Baseline Participants | 151 | 152 | 303 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 151 participants | 152 participants | 303 participants | |
5 (0.14) | 5 (0.14) | 5 (0.14) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 151 participants | 152 participants | 303 participants | |
Female |
81 53.6%
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68 44.7%
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149 49.2%
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Male |
70 46.4%
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84 55.3%
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154 50.8%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 151 participants | 152 participants | 303 participants |
African heritage/African American |
1 0.7%
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0 0.0%
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1 0.3%
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Asian-Central/South Asian heritage |
1 0.7%
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4 2.6%
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5 1.7%
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White-Arabic/North African heritage |
2 1.3%
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0 0.0%
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2 0.7%
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White-Caucasian/European heritage |
147 97.4%
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147 96.7%
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294 97.0%
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Not specified |
0 0.0%
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1 0.7%
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1 0.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
Publications:
Ferrera G et al. A comparison of the immunogenicity and safety of a booster dose of reduced-antigen-content with full-strength DTPa-IPV vaccines administered with MMRV to children 5-6 years of age. Abstract presented at the 44th Congresso Nazionale Societa Italiana di Igiene, Medicina Preventiva e Sanita Pubblica (SITI). Venezia, Italia, 3-6 October, 2010.
Ferrera G et al. Immunogenicity and safety of Booster vaccination with reduced-antigen-content or full-strength Diphtheria-Tetanus-Acellular-Pertussis-IPV vaccines in pre-school children, primed with a 2+1 schedule. Abstract presented at the 29th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). The Hague, The Netherlands, 7-11 June 2011.
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00871000 |
Other Study ID Numbers: |
111815 |
First Submitted: | March 26, 2009 |
First Posted: | March 30, 2009 |
Results First Submitted: | March 7, 2017 |
Results First Posted: | April 18, 2017 |
Last Update Posted: | June 6, 2018 |