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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00322335 |
This protocol posting deals with objectives & outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives
Condition | Intervention | Phase |
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Haemophilus Influenzae Type b Disease Meningococcal Serogroup C Diseases |
Biological: Engerix-B Biological: Infanrix™ hexa Biological: Meningitec™ Biological: Infanrix™ IPV/HIB Biological: Haemophilus influenzae type b- and meningococcal (vaccine) Biological: Infanrix™ penta Biological: NeisVac-C™ |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Phase III Study to Assess Long-Term Persistence of a Booster Dose of GSK Biologicals' Hib-MenC vs a Booster Dose of Infanrix™ Hexa When Given to Subjects (14m) Primed in DTPa-HBV-IPV-097 & Boosted in Hib-MenC-TT-010 BST: DTPa-HBV-IPV-097 |
Estimated Enrollment: | 357 |
Study Start Date: | May 2006 |
Study Completion Date: | July 2006 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group MenCCRM: Active Comparator
Subjects were primed with Infanrix™ hexa + Meningitec™ at 2, 4 and 6 months of age, followed by a booster dose of Infanrix™ hexa at 14 months of age. No vaccines were administered during this long-term persistence phase of the study |
Biological: Infanrix™ hexa
Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).
Biological: Meningitec™
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
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Group NeisPoo: Active Comparator
Subjects were either primed with Infanrix™ hexa + NeisVac-C™ at 2 and 4 months of age and Infanrix™ hexa alone at 6 months of age or with Engerix-B at birth, Infanrix™ hexa + NeisVac-C™ at 2 months of age, Infanrix™ IPV/Hib + NeisVac-C™ at 4 months of age and Infanrix™ hexa alone at 6 months of age. All subjects were boosted with Hib-MenC at 14 months of age. No vaccines were administered during this long-term persistence phase of the study. |
Biological: Engerix-B
Intramuscular injection into the thigh as a birth dose
Biological: Infanrix™ hexa
Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).
Biological: Infanrix™ IPV/HIB
Intramuscular injection into the thigh as primary vaccination at 4 months of age
Biological: Haemophilus influenzae type b- and meningococcal (vaccine)
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).
Biological: NeisVac-C™
Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.
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Group HibMenC: Experimental
Subjects were primed with Infanrix™ penta + Hib-MenC at 2, 4 and 6 months of age, followed by a booster dose of Hib-MenC at 14 months of age. No vaccines were administered during this long-term persistence phase of the study
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Biological: Haemophilus influenzae type b- and meningococcal (vaccine)
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).
Biological: Infanrix™ penta
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
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This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 217744/097 (DTPa-HBV-IPV-097) and will not be further randomized in this study. The study has 3 groups with Meningitec™ primed group as control. The protocol was amended to allow for enrolment of subjects of the Meningitec™ primed control group who were boosted with Meningitec™ after the end of the booster study as per new local reccommendation in Spain.
Ages Eligible for Study: | 31 Months to 33 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
GSK Investigational Site | |
Marid, Spain, 28040 | |
GSK Investigational Site | |
Madrid, Spain, 28007 | |
GSK Investigational Site | |
Madrid, Spain, 28047 | |
GSK Investigational Site | |
Gerona, Spain, 17002 | |
GSK Investigational Site | |
Almería, Spain, 04009 | |
GSK Investigational Site | |
Vélez-Málaga / Málaga, Spain, 29700 | |
GSK Investigational Site | |
Valladolid, Spain, 47010 | |
GSK Investigational Site | |
Getafe/Madrid, Spain, 28905 | |
GSK Investigational Site | |
Madrid, Spain, 28041 | |
GSK Investigational Site | |
Burgos, Spain, 09005 | |
GSK Investigational Site | |
Málaga, Spain, 29011 | |
GSK Investigational Site | |
Móstoles/Madrid, Spain, 28935 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 106672, 106673, 106675, 106679, 106680 |
Study First Received: | May 4, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00322335 History of Changes |
Health Authority: | Spain: Agencia Española del Medicamento |
H.influenzae type b Disease |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Haemophilus Influenzae |
Influenza, Human Fondaparinux Orthomyxoviridae Infections Org 31540 |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |