Clinical Trial Results:
A phase IIIb multi-centre, open, controlled study to assess the immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b – meningococcal serogroup C conjugate (Hib-MenC) vaccine (Menitorix) in preterm and full-term infants when co-administered with GSK Biologicals’ DTPa-HBV-IPV vaccine (Infanrix penta) and with Wyeth’s 7-valent pneumococcal conjugate vaccine (Prevenar) and given according to a 2, 4 and 6 months of age primary vaccination schedule and when given as a booster dose with concomitant GSK Biologicals’ DTPa-IPV vaccine (Infanrix IPV) and Wyeth’s Prevenar in the second year of life.
Estudio fase IIIb abierto, multicéntrico, controlado, para evaluar la inmunogenicidad, reactogenicidad y seguridad de la vacuna conjugada frente a Haemophilus Influenzae tipo b y Meningococo del serogrupo C (Hib-MenC) (Menitorix) de GSK Biologicals en niños prematuros y nacidos a término cuando se administra simultáneamente con la vacuna DTPa-HBV-IPV de GSK Biologicals (Infanrix penta) y con la vacuna conjugada antineumocócica 7-valente de Wyeth (Prevenar) administrada como pauta primaria de vacunación a los 2, 4 y 6 meses de edad y cuando se administra como dosis de recuerdo simultáneamente con la vacuna DTPa-IPV de GSK Biologicals (Infanrix IPV) y Prevenar en el segundo año de vida.
Summary
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EudraCT number |
2007-001167-29 |
Trial protocol |
ES |
Global end of trial date |
30 Dec 2008
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Results information
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Results version number |
v1 |
This version publication date |
27 Apr 2016
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First version publication date |
23 Jan 2015
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Other versions |
v2 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
110215, 110217
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00586612 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l'institut 89, Rixensart, Belgium, 1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 32 2 656 81 11, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 32 2 656 81 11, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Apr 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Dec 2008
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Dec 2008
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Primary vaccination
At one month after the third dose (Post dose 3) in preterm and full-term infants:
•To evaluate the immunogenicity of GSK Biologicals’ Hib-MenC vaccine when given concomitantly with GSK Biologicals’ DTPa-HBV-IPV vaccine and Wyeth’s 7-valent pneumococcal vaccine, in terms of percentage of subjects with:
- Anti-PRP concentration >=0.15 microg/ml
- rSBA-MenC titre >=1:8
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Protection of trial subjects |
All subjects were supervised for 30 min after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Dec 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 313
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Worldwide total number of subjects |
313
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EEA total number of subjects |
313
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
313
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||
Pre-assignment
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Screening 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. | |||||||||||||||||||||
Period 1
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Period 1 title |
Primary phase
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Preterm group | |||||||||||||||||||||
Arm description |
Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Menitorix™
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
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Investigational medicinal product name |
Infanrix™ penta
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 3 doses in the primary study
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Investigational medicinal product name |
Prevenar™
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
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Investigational medicinal product name |
Infanrix™ IPV
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 1 dose in the Booster study.
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Arm title
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Full-term group | |||||||||||||||||||||
Arm description |
Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
Investigational medicinal product name |
Menitorix™
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Investigational medicinal product code |
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Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
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Investigational medicinal product name |
Infanrix™ penta
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 3 doses in the primary study
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Investigational medicinal product name |
Prevenar™
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
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Investigational medicinal product name |
Infanrix™ IPV
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 1 dose in the Booster study.
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Period 2
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Period 2 title |
Booster phase
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Is this the baseline period? |
No | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Preterm group | |||||||||||||||||||||
Arm description |
Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Menitorix™
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Investigational medicinal product code |
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Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
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Investigational medicinal product name |
Infanrix™ penta
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 3 doses in the primary study
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Investigational medicinal product name |
Prevenar™
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
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Investigational medicinal product name |
Infanrix™ IPV
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 1 dose in the Booster study.
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Arm title
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Full-term group | |||||||||||||||||||||
Arm description |
Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
Investigational medicinal product name |
Menitorix™
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Investigational medicinal product code |
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Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
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Investigational medicinal product name |
Infanrix™ penta
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 3 doses in the primary study
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|||||||||||||||||||||
Investigational medicinal product name |
Prevenar™
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
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Investigational medicinal product name |
Infanrix™ IPV
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Investigational medicinal product code |
||||||||||||||||||||||
Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Intramuscular injection, 1 dose in the Booster study.
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Notes [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: Not all the subjects enrolled in the Primary phase started the Booster phase. |
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Baseline characteristics reporting groups
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Reporting group title |
Preterm group
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Reporting group description |
Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Full-term group
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Reporting group description |
Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Preterm group
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Reporting group description |
Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. | ||
Reporting group title |
Full-term group
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Reporting group description |
Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. | ||
Reporting group title |
Preterm group
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Reporting group description |
Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. | ||
Reporting group title |
Full-term group
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Reporting group description |
Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. |
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End point title |
Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to 0.15 micrograms per milliliter (µg/mL) [1] | ||||||||||||
End point description |
Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.
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End point type |
Primary
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End point timeframe |
One month after the third vaccination
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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End point title |
Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer greater than or equal to 1:8 [2] | ||||||||||||
End point description |
rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.
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End point type |
Primary
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End point timeframe |
One month after the third vaccination
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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End point title |
Number of subjects with Anti-Polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to the cut-off values | |||||||||||||||
End point description |
Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.
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End point type |
Secondary
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End point timeframe |
Before vaccination (at Day 0)
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No statistical analyses for this end point |
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End point title |
Number of subject with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to 1 microgram per milliliter | ||||||||||||
End point description |
Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL).
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End point type |
Secondary
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End point timeframe |
One month after the third vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer greater than or equal to the cut-off values | ||||||||||||||||||
End point description |
rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.
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End point type |
Secondary
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End point timeframe |
Before vaccination (at Day 0)
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No statistical analyses for this end point |
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End point title |
Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer greater than or equal to the cut-off values | |||||||||||||||
End point description |
rSBA-MenC titer cut-off values assessed include 1:32 and 1:128.
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End point type |
Secondary
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End point timeframe |
One month after the third vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with Anti-polysaccharide C (anti-PSC) antibody concentration greater than or equal to (≥) the cut-off values | |||||||||||||||
End point description |
Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.
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End point type |
Secondary
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End point timeframe |
Before vaccination (at Day 0)
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No statistical analyses for this end point |
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End point title |
Number of subjects with Anti-polysaccharide C (anti-PSC) antibody concentration greater than or equal to (≥) the cut-off values | |||||||||||||||
End point description |
Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.
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End point type |
Secondary
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End point timeframe |
One month after the third dose
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No statistical analyses for this end point |
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End point title |
Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentration greater than or equal to (≥) the cut-off values | |||||||||||||||
End point description |
Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.
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End point type |
Secondary
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End point timeframe |
Before vaccination (at Day 0)
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No statistical analyses for this end point |
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End point title |
Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentration greater than or equal to (≥) the cut-off values | |||||||||||||||
End point description |
Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
One month after the third dose
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Anti-polyribosylribitol phosphate (anti-PRP) and anti-polysaccharide C (anti-PSC) concentration | ||||||||||||||||||
End point description |
Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Before vaccination (at Day 0)
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Anti-polyribosylribitol phosphate (anti-PRP) and anti-polysaccharide C (anti-PSC) concentration | ||||||||||||||||||
End point description |
Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
One month after the third dose
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Anti-hepatitis B surface antigen (anti-HBs) concentration | |||||||||||||||
End point description |
Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Before vaccination (at Day 0)
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Anti-hepatitis B surface antigen (anti-HBs) concentration | |||||||||||||||
End point description |
Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
One month after the third dose
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer | |||||||||||||||
End point description |
rSBA-MenC titers are given as geometric mean titers (GMTs).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Before vaccination (at Day 0)
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer | |||||||||||||||
End point description |
rSBA-MenC titers are given as geometric mean titers (GMTs).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
One month after the third dose
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of subjects reporting solicited local symptoms | ||||||||||||||||||
End point description |
Solicited local symptoms assessed include pain, redness and swelling and are presented across doses.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
During the 4-day follow-up period after any primary vaccination dose
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects reporting solicited general symptoms | |||||||||||||||||||||
End point description |
Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite and are presented across doses.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
During the 4-day follow-up period after any primary vaccination dose
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting unsolicited adverse events (AEs) | ||||||||||||
End point description |
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Within 31 days after each primary vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting serious adverse events (SAEs) | ||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Throughout the entire primary vaccination phase
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to 0.15 migrogram per milliliter (µg/mL) | |||||||||||||||
End point description |
Anti-PRP antibody cut-off value assessed was 0.15 migrogram per milliliter (µg/mL).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Prior to (Month 14) and one month after the booster vaccination (Month 15)
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentration greater than or equal to 1.0 migrogram per milliliter (µg/mL) | |||||||||||||||
End point description |
Anti-PRP antibody cut-off value assessed was 1.0 migrogram per milliliter (µg/mL).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Prior to (Month 14) and one month after the booster vaccination (Month 15)
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer greater than or equal to the cut-off values | |||||||||||||||||||||||||||
End point description |
rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Prior to (Month 14) and one month after the booster vaccination (Month 15)
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with anti-polysaccharide C (anti-PSC) antibody concentration greater than or equal to the cut-off values | |||||||||||||||||||||
End point description |
Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2.0 µg/mL.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Prior to (Month 14) and one month after the booster vaccination (Month 15)
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentration greater than or equal to the cut-off values | |||||||||||||||
End point description |
Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL. Note: the protocol planned an analysis on HBs after the booster dose, but this analysis was not performed as the vaccines administered as booster doses did not contain HBs component.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Prior to (Month 14) the booster vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Anti-polyribosylribitol phosphate (anti-PRP) and anti-polysaccharide C (anti-PSC) concentration | ||||||||||||||||||||||||
End point description |
Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL).
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Prior to (Month 14) and one month after the booster vaccination (Month 15)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Anti-hepatitis B surface antigen (anti-HBs) concentration | |||||||||||||||
End point description |
Anti-HBs concentrations are given as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL). Note: Planned analysis in the protocol of HBs after the booster dose was not performed as booster vaccines did not contain HBs component.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Prior to (Month 14) the booster vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Meningococcal serogroup C serum bactericidal assay using rabbit complement (rSBA-MenC) titer | ||||||||||||||||||
End point description |
rSBA-MenC titers are given as geometric mean titers (GMTs).
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Prior to (Month 14) and one month after the booster vaccination (Month 15)
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Number of subjects reporting solicited symptoms (local and general) | ||||||||||||||||||||||||||||||
End point description |
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite.
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
During the 4-day follow-up period following booster vaccination
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting unsolicited adverse events (AEs) | ||||||||||||
End point description |
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Within 31 days after the booster vaccination (month 15)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects reporting serious adverse events (SAEs) | |||||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Period 1 is defined as 31 days after last primary vaccination until administration of booster dose (Month 14). Period 2 is defined as the administration of the booster dose until the end of the study (Month 15).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
31 days after last primary vaccination until administration of booster dose (Month 14) and from the administration of the booster dose until the end of the study (Month 15)
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.
|
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10
|
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Reporting groups
|
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Reporting group title |
Preterm group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Full-term group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |