Pertussis and Meningitis C Concomitant Vaccination in Adolescents

NCT02526394 | Completed Phase 4

• 1 other identifier: Multiboost
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

The trial includes groups receiving various combinations of meningitis C and pertussis containing vaccines, to be administered concomitantly in adolescents due their school leaving booster vaccinations (as per UK routine immunisation schedule at 13-17 years of age). Immunogenicity and reactogenicity will be assessed.

Conditions

Pertussis; Meningitis; Preventive Immunization; Meningitis; Immunization

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects with serogroup C rabbit serum bactericidal assay (rSBA) titres ≥ 8 and ≥ 128 and rSBA geometric mean titre (GMTs) (and percentage with ≥ 4 fold rise compared to baseline).

  response to meningococcal vaccination

  Day 28 following vaccination

• Pertussis antigen-specific antibody geometric mean concentration (GMCs) in IU/mL for pertussis toxin (PT), Pertactin, and filamentous haemaglutinnin (FHA) and in U/ml for fimbreal antigens (Fims) 2 and 3

  response to pertussis vaccination

  Day 28 following vaccination

Secondary Outcomes (3)

• Tetanus -specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL

  Day 28 following vaccination

• Heamophilus type b (Hib)-polyribosylribitol phosphate(PRP)-specific IgG GMCs and proportions achieving IgG concentrations of ≥0.15 or ≥1.00 μg/ml

  Day 28 following vaccination

• Diphtheria-specific IgG GMCs in IU/mL and percentages above 0.1 IU/mL

  Day 28 following vaccination

Study Arms (8)

1

ACTIVE COMPARATOR

Repevax + Meningitec

Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine

2

ACTIVE COMPARATOR

Repevax + Neis-VacC

Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine

3

ACTIVE COMPARATOR

Repevax + Menitorix

Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine

4

ACTIVE COMPARATOR

Boostrix + Meningitec

Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine

5

ACTIVE COMPARATOR

Boostrix + NeisVacC

Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine

6

ACTIVE COMPARATOR

Boostrix + Menitorix

Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine

7

ACTIVE COMPARATOR

Repevax + quadrivalent meningococcal conjugate )Nimenrix / Menveo)

Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine

8

ACTIVE COMPARATOR

Boostrix + quadrivalent meningococcal conjugate )Nimenrix / Menveo)

Biological: Meningococcal vaccine; Drug: Pertussis containing vaccine

Interventions

Meningococcal vaccine BIOLOGICAL

Meningococcal vaccination

Also known as: Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix

1; 2; 3; 4; 5; 6; 7; 8

Pertussis containing vaccine DRUG

Pertussis containing vaccination

Also known as: Boostrix, Repevax

1; 2; 3; 4; 5; 6; 7; 8

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participant is willing and able to give written informed consent for participation. If aged below 16 years, parent/legal guardian gives consent while the participant gives written assent for participation in the study.
• Male or female aged 13 years and 6 months (+0 day) to 17 years (+364 days) on the day of consent.
• Completed childhood meningococcal serogroup C and pertussis vaccination according to the UK (catch-up and/or routine) schedule appropriate for the participant's age

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Any contraindication to vaccination as specified in the "Green Book"- Immunisation against Infectious Disease.
• Significant illness including progressive neurological disease or seizure disorder; confirmed or suspected immunosuppressive or immunodeficient conditions; major congenital defects; or known bleeding diathesis (or any condition that may be associated with a prolonged bleeding time).
• Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• History of invasive meningococcal disease or pertussis.
• Significant contact (household or intimate exposure) to an individual with culture proven Neisseria meningitis disease or pertussis in the previous 60 days.
• Received the routine teenage booster dose of tetanus/diphtheria/polio
• Pregnancy
• Fever (sublingual temperature ≥ 38°C)
• Received systemic antibiotic(s) (either oral or parenteral) within the past 7 days. For all visits, if allowed by the study visit window, receipt of systemic antibiotics (either oral or parenteral) will delay venepuncture until at least 7 days after cessation of antibiotics.
• Received any blood or blood products within the past 12 weeks.
• Received another investigational agent within 90 days - or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial to the end of this study.
• Possibility of pregnancy

Sponsors & Collaborators

• Public Health England: lead

Study Sites (2)

Gloucestershire primary care

Gloucestershire, Gloucestershire, United Kingdom

Location

Hertfordshire primary care

Hertfordshire, Hertfordshire, United Kingdom

Location

MeSH Terms

Conditions

Whooping Cough; Meningitis

Interventions

Meningococcal Vaccines; Boostrix

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neuroinflammatory Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 18, 2015
• Study Start: September 1, 2013
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: March 22, 2019

Record last verified: 2018-04

Locations

GB (2)