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Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines

NCT ID: NCT01144663

Last Updated: 2020-12-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2095 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-01

Study Completion Date

2013-09-10

Brief Summary

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The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be co-administered.

Detailed Description

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The study consists of a primary vaccination phase and a booster vaccination phase. The Protocol Posting has been updated due to protocol amendment 2.

Conditions

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Infections, Meningococcal Meningococcal Vaccines

Keywords

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Infants conjugate vaccine immunogenicity meningococcal vaccine non-inferiority co-administration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Nimenrix 3 Group

Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.

Group Type EXPERIMENTAL

Nimenrix™

Intervention Type BIOLOGICAL

4- or 3-dose intramuscular injection

Infanrix™ hexa

Intervention Type BIOLOGICAL

4-dose intramuscular injection

Synflorix™

Intervention Type BIOLOGICAL

4-dose intramuscular injection

Nimenrix 2 Group

Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.

Group Type EXPERIMENTAL

Nimenrix™

Intervention Type BIOLOGICAL

4- or 3-dose intramuscular injection

Infanrix™ hexa

Intervention Type BIOLOGICAL

4-dose intramuscular injection

Synflorix™

Intervention Type BIOLOGICAL

4-dose intramuscular injection

Menjugate Group

Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.

Group Type ACTIVE_COMPARATOR

Menjugate®

Intervention Type BIOLOGICAL

3-dose intramuscular injection

Infanrix™ hexa

Intervention Type BIOLOGICAL

4-dose intramuscular injection

Synflorix™

Intervention Type BIOLOGICAL

4-dose intramuscular injection

NeisVac-C Group

Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.

Group Type ACTIVE_COMPARATOR

NeisVac-CTM

Intervention Type BIOLOGICAL

3-dose intramuscular injection

Infanrix™ hexa

Intervention Type BIOLOGICAL

4-dose intramuscular injection

Synflorix™

Intervention Type BIOLOGICAL

4-dose intramuscular injection

Interventions

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Nimenrix™

4- or 3-dose intramuscular injection

Intervention Type BIOLOGICAL

Menjugate®

3-dose intramuscular injection

Intervention Type BIOLOGICAL

NeisVac-CTM

3-dose intramuscular injection

Intervention Type BIOLOGICAL

Infanrix™ hexa

4-dose intramuscular injection

Intervention Type BIOLOGICAL

Synflorix™

4-dose intramuscular injection

Intervention Type BIOLOGICAL

Other Intervention Names

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Infanrix hexa™

Eligibility Criteria

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Inclusion Criteria

All subjects must satisfy ALL the following criteria at study entry:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
* A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s) or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of at least 36 weeks.

Exclusion Criteria

* Child in care.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Extended administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone \>= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) until 30 days after the last dose of vaccine(s) (i.e. booster dose), with the exception of rotavirus vaccine which can be administered at any time during the study, according to the national immunisation recommendations. MMR(V) vaccine, if recommended in national immunisation programs, can be given after the last blood sampling time point i.e. after Visit 6. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Streptococcus pneumoniae, Neisseria meningitidis serogroups A, C, W-135 or Y with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations (for example hepatitis B and BCG).
* History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures (history of a single, simple febrile seizure is permitted).
* Acute disease and/or fever at the time of enrolment. (Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting, or ≥ 38.0°C (100.4°F) on rectal setting).

(Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator).

\- Administration of immunoglobulins and/ or any blood products since birth or planned administration during the study period.
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Haabneeme, , Estonia

Site Status

GSK Investigational Site

Tallinn, , Estonia

Site Status

GSK Investigational Site

Tallinn, , Estonia

Site Status

GSK Investigational Site

Tallinn, , Estonia

Site Status

GSK Investigational Site

Tartu, , Estonia

Site Status

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Berchtesgaden, Bavaria, Germany

Site Status

GSK Investigational Site

Bindlach, Bavaria, Germany

Site Status

GSK Investigational Site

Gilching, Bavaria, Germany

Site Status

GSK Investigational Site

Kirchheim, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Weilheim, Bavaria, Germany

Site Status

GSK Investigational Site

Baunatal-Grossenritte, Hesse, Germany

Site Status

GSK Investigational Site

Eschwege, Hesse, Germany

Site Status

GSK Investigational Site

Vellmar, Hesse, Germany

Site Status

GSK Investigational Site

Detmold, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Porta Westfalica, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Solingen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Worms, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Leipzig, Saxony, Germany

Site Status

GSK Investigational Site

Wurzen, Saxony, Germany

Site Status

GSK Investigational Site

Wanzleben, Saxony-Anhalt, Germany

Site Status

GSK Investigational Site

Weißenfels, Saxony-Anhalt, Germany

Site Status

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Bad Lobenstein, Thuringia, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Almería, , Spain

Site Status

GSK Investigational Site

Antequera/Málaga, , Spain

Site Status

GSK Investigational Site

Badalona, , Spain

Site Status

GSK Investigational Site

Blanes (Girona), , Spain

Site Status

GSK Investigational Site

Burgos, , Spain

Site Status

GSK Investigational Site

Ciudad Real, , Spain

Site Status

GSK Investigational Site

Manlleu, , Spain

Site Status

GSK Investigational Site

Seville, , Spain

Site Status

GSK Investigational Site

Valencia, , Spain

Site Status

GSK Investigational Site

Valladolid, , Spain

Site Status

GSK Investigational Site

Vic, , Spain

Site Status

Countries

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Estonia Germany Spain

References

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Merino Arribas JM, Carmona Martinez A, Horn M, Perez Porcuna XM, Otero Reigada MD, Mares Bermudez J, Centeno Malfaz F, Miranda M, Mendez M, Garcia Cabezas MA, Wittermann C, Bleckmann G, Fischbach T, Kolhe D, van der Wielen M, Baine Y. Safety and Immunogenicity of the Quadrivalent Meningococcal Serogroups A, C, W and Y Tetanus Toxoid Conjugate Vaccine Coadministered With Routine Childhood Vaccines in European Infants: An Open, Randomized Trial. Pediatr Infect Dis J. 2017 Apr;36(4):e98-e107. doi: 10.1097/INF.0000000000001484.

Reference Type BACKGROUND
PMID: 28002359 (View on PubMed)

Merino Arribas JM, Carmona Martinez A, Horn M, Perez Porcuna XM, Otero Reigada MDC, Mares Bermudez J, Centeno Malfaz F, Miranda M, Mendez M, Garcia Cabezas MA, Christoph W, Bleckmann G, Fischbach T, Kolhe D, Van der Wielen M, Baine Y. Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib and PHiD-CV When Coadministered With MenACWY-TT in Infants: Results of an Open, Randomized Trial. Pediatr Infect Dis J. 2018 Jul;37(7):704-714. doi: 10.1097/INF.0000000000002061.

Reference Type BACKGROUND
PMID: 29620722 (View on PubMed)

Other Identifiers

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2009-016841-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

113369

Identifier Type: -

Identifier Source: org_study_id