Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant vaccines were given to all children to complete the vaccination agenda.
Five parallel treatment groups receiving a 3-dose primary vaccination course: MenC-TT vaccine (2 formulations, double-blind) + Infanrix hexa® OR Hib-MenC-TT (2 formulations double-blind) + Infanrix penta® OR Meningitec™ + Infanrix hexa® (control). Three blood samples taken, before dose 1 and one month after dose 2 and dose 3.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenC-TT | Biological | |||
| Hib-MenC-TT | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Meningococcal C serum bactericidal assay using rabbit complement (rSBA-MenC) antibody titers ≥ 1:8 & ≥ 1:128 and titers | Prior to vaccination, one month after the 2nd and 3rd vaccine doses | |
| Evaluation of anti-polysaccharide C (anti-PSC) antibody concentrations ≥ 0.3 µg/mL & ≥ 2 µg/mL and concentrations | Prior to vaccination, one month after the 2nd and 3rd vaccine doses | |
| Evaluation of anti-polyribosyl ribitol phosphate (anti-PRP) antibody concentrations ≥ 0.15 µg/mL & ≥ 1 µg/mL and concentrations | Prior to vaccination, one month after the 2nd and 3rd vaccine doses | |
| Evaluation of anti-diphtheria antibody concentrations ≥ 0.1 IU/mL by ELISA | Prior to and one month after the 3rd vaccine dose | |
| Evaluation of anti-tetanus antibody concentrations ≥ 0.1 IU/mL | Prior to and one month after the 3rd vaccine dose | |
| Evaluation of anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 10 mIU/mL | Prior to and one month after the 3rd vaccine dose | |
| Evaluation of anti-poliovirus types 1, 2 and 3 antibody titers ≥ 8 mIU/mL | Prior to and one month after the 3rd vaccine dose | |
| Vaccine response to pertussis toxoid (PT) | Prior to 3rd vaccine dose | |
| Evaluation of anti-diphtheria antibody concentrations |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17287313 | Derived | Schmitt HJ, Maechler G, Habermehl P, Knuf M, Saenger R, Begg N, Boutriau D. Immunogenicity, reactogenicity, and immune memory after primary vaccination with a novel Haemophilus influenzae-Neisseria meningitidis serogroup C conjugate vaccine. Clin Vaccine Immunol. 2007 Apr;14(4):426-34. doi: 10.1128/CVI.00377-06. Epub 2007 Feb 7. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 711202/001 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Prior to 3rd vaccine dose |
| Anti-poliovirus types 1, 2 and 3 antibody titers | Prior to and one month after the 3rd vaccine dose |
| Occurrence of solicited local injection site symptoms | During the solicited follow-up period (Day 0 7) following administration of each vaccine dose |
| Occurrence of solicited systemic symptoms | During the solicited follow-up period (Day 0 7) following administration of each vaccine dose |
| Occurrence of unsolicited non-serious adverse events (AEs) | Within one month (Day 0 30) after each vaccination |
| Occurrence of any serious adverse events (SAEs) | Throughout the entire study period up to and including one month (maximum 30 days) after the last vaccine dose |
| Vaccine response to pertussis toxoid (PT) | One month after the 3rd vaccine dose |
| Vaccine response to filamentous haemagglutinin (FHA) | Prior to 3rd vaccine dose |
| Vaccine response to filamentous haemagglutinin (FHA) | One month after the 3rd vaccine dose |
| Vaccine response to pertactin (PRN) | Prior to 3rd vaccine dose |
| Vaccine response to pertactin (PRN) | One month after the 3rd vaccine dose |
| Evaluation of anti-diphtheria antibody concentrations | One month after the 3rd vaccine dose |
| Evaluation of anti-tetanus antibody concentrations | Prior to 3rd vaccine dose |
| Evaluation of anti-tetanus antibody concentrations | One month after the 3rd vaccine dose |
| Evaluation of anti-HBs antibody concentrations | Prior to 3rd vaccine dose |
| Evaluation of anti-HBs antibody concentrations | One month after the 3rd vaccine dose |
| Evaluation of anti-PT antibody concentrations | Prior to 3rd vaccine dose |
| Evaluation of anti-PT antibody concentrations | One month after the 3rd vaccine dose |
| Evaluation of anti-FHA antibody concentrations | Prior to 3rd vaccine dose |
| Evaluation of anti-FHA antibody concentrations | One month after the 3rd vaccine dose |
| Evaluation of anti-PRN antibody concentrations | Prior to 3rd vaccine dose |
| Evaluation of anti-PRN antibody concentrations | One month after the 3rd vaccine dose |
For additional information about this study please refer to the GSK Clinical Study Register |
| 711202/001 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 711202/001 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 711202/001 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 711202/001 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 711202/001 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D007239 | Infections |