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

NCT01144663 | Completed Phase 3 Results

• 2 other identifiers: 1133692009-016841-24
• Study Type: interventional
• Target: 2,095
• Locations: 2 countries
• Sites: 33

Brief Summary

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.

Conditions

Infections, Meningococcal; Meningococcal Vaccines

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.

  The cut-off value for the rSBA-MenA, rSBA-MenW-135 and rSBA-Y titers was greater than or equal to (≥) 1:8. Indication of the immunogenicity of the 2-dose and 3-dose schedules: the lower limit of the two-sided exact 95% CI for the percentage of subjects with post-primary vaccination rSBA antibody titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.

  One month after the final primary vaccination at Month 3

• Number of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off Value

  The cut-off value for rSBA-MenC titers was ≥ 1:8.

  One month after the final primary vaccination at Month 3

Secondary Outcomes (47)

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values

  Pre-primary vaccination at Month 0

• rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers

  Pre-primary vaccination at Month 0

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values

  Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

• rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers

  Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11

• Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values

  Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3

Study Arms (4)

Nimenrix 3 Group

EXPERIMENTAL

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.

Biological: Nimenrix™; Biological: Infanrix™ hexa; Biological: Synflorix™

Nimenrix 2 Group

EXPERIMENTAL

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.

Biological: Nimenrix™; Biological: Infanrix™ hexa; Biological: Synflorix™

Menjugate Group

ACTIVE COMPARATOR

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.

Biological: Menjugate®; Biological: Infanrix™ hexa; Biological: Synflorix™

NeisVac-C Group

ACTIVE COMPARATOR

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.

Biological: NeisVac-CTM; Biological: Infanrix™ hexa; Biological: Synflorix™

Interventions

Nimenrix™ BIOLOGICAL

4- or 3-dose intramuscular injection

Nimenrix 2 Group; Nimenrix 3 Group

Menjugate® BIOLOGICAL

3-dose intramuscular injection

Menjugate Group

NeisVac-CTM BIOLOGICAL

3-dose intramuscular injection

NeisVac-C Group

Infanrix™ hexa BIOLOGICAL

4-dose intramuscular injection

Also known as: Infanrix hexa™

Menjugate Group; NeisVac-C Group; Nimenrix 2 Group; Nimenrix 3 Group

Synflorix™ BIOLOGICAL

4-dose intramuscular injection

Menjugate Group; NeisVac-C Group; Nimenrix 2 Group; Nimenrix 3 Group

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (44)

GSK Investigational Site

Haabneeme, 74001, Estonia

Location

GSK Investigational Site

Tallinn, 10117, Estonia

Location

GSK Investigational Site

Tallinn, 10617, Estonia

Location

GSK Investigational Site

Tallinn, Estonia

Location

GSK Investigational Site

Tartu, 51014, Estonia

Location

GSK Investigational Site

Kehl, Baden-Wurttemberg, 77694, Germany

Location

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

Location

GSK Investigational Site

Berchtesgaden, Bavaria, 83471, Germany

Location

GSK Investigational Site

Bindlach, Bavaria, 95463, Germany

Location

GSK Investigational Site

Gilching, Bavaria, 82205, Germany

Location

GSK Investigational Site

Kirchheim, Bavaria, 85551, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81241, Germany

Location

GSK Investigational Site

Weilheim, Bavaria, 82362, Germany

Location

GSK Investigational Site

Baunatal-Grossenritte, Hesse, 34225, Germany

Location

GSK Investigational Site

Eschwege, Hesse, 37269, Germany

Location

GSK Investigational Site

Vellmar, Hesse, 34246, Germany

Location

GSK Investigational Site

Detmold, North Rhine-Westphalia, 32756, Germany

Location

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, 47533, Germany

Location

GSK Investigational Site

Porta Westfalica, North Rhine-Westphalia, 32457, Germany

Location

GSK Investigational Site

Solingen, North Rhine-Westphalia, 42719, Germany

Location

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Trier, Rhineland-Palatinate, 54290, Germany

Location

GSK Investigational Site

Worms, Rhineland-Palatinate, 67547, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04178, Germany

Location

GSK Investigational Site

Wurzen, Saxony, 04808, Germany

Location

GSK Investigational Site

Wanzleben, Saxony-Anhalt, 39164, Germany

Location

GSK Investigational Site

Weißenfels, Saxony-Anhalt, 06667, Germany

Location

GSK Investigational Site

Flensburg, Schleswig-Holstein, 24937, Germany

Location

GSK Investigational Site

Bad Lobenstein, Thuringia, 07356, Germany

Location

GSK Investigational Site

Berlin, 12157, Germany

Location

GSK Investigational Site

Berlin, 13055, Germany

Location

GSK Investigational Site

Berlin, 14197, Germany

Location

GSK Investigational Site

Almería, 04009, Spain

Location

GSK Investigational Site

Antequera/Málaga, 29200, Spain

Location

GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Blanes (Girona), 17300, Spain

Location

GSK Investigational Site

Burgos, 09006, Spain

Location

GSK Investigational Site

Ciudad Real, 13005, Spain

Location

GSK Investigational Site

Manlleu, 08560, Spain

Location

GSK Investigational Site

Seville, 41014, Spain

Location

GSK Investigational Site

Valencia, 46026, Spain

Location

GSK Investigational Site

Valladolid, 47012, Spain

Location

GSK Investigational Site

Vic, 08500, Spain

Location

Related Publications (2)

• 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.

  PMID: 28002359 BACKGROUND

• 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.

  PMID: 29620722 BACKGROUND

MeSH Terms

Conditions

Meningococcal Infections

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; PHiD-CV vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 15, 2010
• Study Start: July 1, 2010
• Primary Completion: June 22, 2012
• Study Completion: September 10, 2013
• Last Updated: December 31, 2020
• Results First Posted: February 1, 2019

Record last verified: 2020-12

Locations

DE (28); ES (5)