Assessing responses to the booster dose of pneumococcal vaccine in children who had less than the standard number of doses as babies, as well as meningococcal B vaccine as babies.

Assessment of post booster antibody responses in UK infants given a reduced priming schedule of meningococcal serogroup B and 13 valent pneumococcal conjugate vaccines - Baby Vaccine Study (Sched3)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000817-32-GB

Enrollment

200

Registered

2015-03-06

Start date

2015-06-22

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunological responses to vaccination in health y participants under reduced dose vaccine schedules MedDRA version: 18.0 Level: PT Classification code 10069578 Term: Pneumococcal immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 18.0 Level: LLT Classification code 10039242 Term: Routine childhood immunisation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Bexsero Product Name: Bexsero Pharmaceutical Form: Injection INN or Proposed INN: recombinant Neiserria Meningitidis group B NHBA fusion protein Concentration unit: µg microgram(s) Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants may only be included in the study if all the inclusion criteria are met: • Infants due to receive their primary immunisations, aged up to 13 weeks on first vaccinations. • Written informed consent given by parent/ guardian Where possible consent will be sought from the mother so that permission can be given for recording any pertussis (whooping cough) containing vaccine in pregnancy. If this is not possible, i.e. if consent is given by the father or legal guardian, then this information would not be collected. Are the trial subjects under 18? yes Number of subjects for this age range: 200 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Infants may not be included in the study if any of the following apply: • Bleeding disorder • Fulfil any of the contraindications to vaccination as specified in The Green Book [DH website]: ? At risk of invasive pneumococcal disease (IPD) defined as ‘Children with asplenia, splenic dysfunction or complement disorders’ and those born prior to 37 weeks gestation ? confirmed anaphylactic reaction to a previous dose of the vaccine, or ? confirmed anaphylactic reaction to any constituent or excipient of the vaccine(s). ? a confirmed anaphylactic reaction to neomycin, streptomycin or polymyxin B (which may be present in trace amounts in the tetanus vaccine) and/or kanamycin, histidine, sodium chloride or sucrose (which may be present in trace amounts in the MenB vaccine). ? Latex hypersensitivity (the syringe cap of Bexsero may contain natural rubber latex) If the infant has an axillary/aural temperature = 38°C on the scheduled appointment day, then vaccination and blood sampling will be postponed until resolution of fever. Blood sampling will also be postponed for seven days after completion of any antibiotic course. (NB if this occurs then this will be documented in the CRF to confirm the order of randomisation was maintained and will give the reason for postponement of treatment)

Design outcomes

Primary

Measure	Time frame
Main Objective: Technical - To assess geometric mean concentrations (GMC) of serotype specific pneumococcal antibody responses measured in the blood sample taken after the final infant vaccinations, usually at 13 months of age, following two or three doses of 13 valent pneumococcal conjugate vaccine (PCV13) at 3 and 12 months or at 2, 4, and 12 months of age Lay - To assess how much antibody can be detected in the blood sample taken a month after the final infant vaccinations, usually taken at 13 months of age, after two or three doses of the routinely used pneumococcal vaccine, called Prevenar13. ;Secondary Objective: Technical: • To assess GMC of serotype specific pneumococcal antibody responses measured in the blood sample taken at 5 months of age, following one or two doses of 13 valent pneumococcal conjugate vaccine (PCV13) at 3 months or at 2 and 4 months of age • To assess antibody responses to MenB vaccination using proportions achieving hSBA titres =4 for the three main MenB vaccine antigen target strains, 5/99 (NadA), NZ98/254 (PorA) and 44/76-SL (fHbp). • To assess antibody responses, by IgG GMC, to the tetanus, diphtheria and pertussis components (pertussis toxin (PT), pertactin (PRN), filamentous heamagglutinin (FHA) and fimbrial antigens (fims) 2 and 3) of Infanrix-IPV-Hib vaccine after three doses at 2, 3 and 4 months of age, from the blood sample taken at 5 months of age • To assess anti-PRP IgG and meningococcal serogroup C (MenC) antibody responses in the blood samples taken at 5 and 13 months of age, by proportions achieving protective antibody levels defined as anti-PRO Ig;Primary end point(s): The primary outcome measure will be the antibody levels measured against the pneumococcal vaccinations, from the blood samples collected when participants are about 13 months of age.;Timepoint(s) of evaluation of this end point: 13 months of age	—

Measure

Time frame

Main Objective: Technical - To assess geometric mean concentrations (GMC) of serotype specific pneumococcal antibody responses measured in the blood sample taken after the final infant vaccinations, usually at 13 months of age, following two or three doses of 13 valent pneumococcal conjugate vaccine (PCV13) at 3 and 12 months or at 2, 4, and 12 months of age Lay - To assess how much antibody can be detected in the blood sample taken a month after the final infant vaccinations, usually taken at 13 months of age, after two or three doses of the routinely used pneumococcal vaccine, called Prevenar13. ;Secondary Objective: Technical: • To assess GMC of serotype specific pneumococcal antibody responses measured in the blood sample taken at 5 months of age, following one or two doses of 13 valent pneumococcal conjugate vaccine (PCV13) at 3 months or at 2 and 4 months of age • To assess antibody responses to MenB vaccination using proportions achieving hSBA titres =4 for the three main MenB vaccine antigen target strains, 5/99 (NadA), NZ98/254 (PorA) and 44/76-SL (fHbp). • To assess antibody responses, by IgG GMC, to the tetanus, diphtheria and pertussis components (pertussis toxin (PT), pertactin (PRN), filamentous heamagglutinin (FHA) and fimbrial antigens (fims) 2 and 3) of Infanrix-IPV-Hib vaccine after three doses at 2, 3 and 4 months of age, from the blood sample taken at 5 months of age • To assess anti-PRP IgG and meningococcal serogroup C (MenC) antibody responses in the blood samples taken at 5 and 13 months of age, by proportions achieving protective antibody levels defined as anti-PRO Ig;Primary end point(s): The primary outcome measure will be the antibody levels measured against the pneumococcal vaccinations, from the blood samples collected when participants are about 13 months of age.;Timepoint(s) of evaluation of this end point: 13 months of age

—

Secondary

Measure	Time frame
Secondary end point(s): • 13 serotype-specific pneumococcal IgG GMCs and functional pneumococcal antibodies and proportions =0.35µg/mL for each serotype in the blood samples taken at 5 and 13 months of age • Titres and proportions of participants achieving antibody responses to MenB vaccination hSBA titres =4 for the three main vaccine antigen target MenB strains, 5/99 (NadA), NZ98/254 (PorA) and 44/76-SL (fHbp) in the blood samples taken at 5 months of age. • Meningococcal serogroup C hSBA GMTs and proportion of infants =4 (5 month blood only); rSBA titres (GMT) and proportion of infants with titres ? 8 and ?128 (13 month blood only) • GMC of anti-PRP IgG [Hib antigen] and proportion of infants with concentrations of > 0.15µg/mL and ? 1.0µg/mL in the blood samples taken at 5 and 13 months of age. • GMC of IgG to pertussis antigens (PT, PRN, FHA and FIM 2 and 3) in the blood samples taken at 5 months of age. • GMC of anti-tetanus toxoid IgG and proportions =0.1 IU/mL and =1.0 IU/mL in the blood samples taken at 5 months of age. • GMC of anti-diphtheria toxoid IgG and proportions =0.1IU/mL and =1.0 IU/mL in the blood samples taken at 5 months of age. From the nasal swab collected prior to the booster vaccinations at 12 months of age and six months later: • Frequency of carriage of identified pneumococcal serotypes From the health diary completed after each vaccination: • Measurement of redness/ swelling/ pain at the injection site and temperature as recorded in the daily health diary for the week following vaccination, as well as any systemic symptoms. Temperature will also be recorded and analysed from the iButton system ;Timepoint(s) of evaluation of this end point: At various timepoints during the course of the study as per each end point listed - usually in the week following immunisation (AEs) or from the blood samples taken at 5 and or 13 months of age.	—

Measure

Time frame

Secondary end point(s): • 13 serotype-specific pneumococcal IgG GMCs and functional pneumococcal antibodies and proportions =0.35µg/mL for each serotype in the blood samples taken at 5 and 13 months of age • Titres and proportions of participants achieving antibody responses to MenB vaccination hSBA titres =4 for the three main vaccine antigen target MenB strains, 5/99 (NadA), NZ98/254 (PorA) and 44/76-SL (fHbp) in the blood samples taken at 5 months of age. • Meningococcal serogroup C hSBA GMTs and proportion of infants =4 (5 month blood only); rSBA titres (GMT) and proportion of infants with titres ? 8 and ?128 (13 month blood only) • GMC of anti-PRP IgG [Hib antigen] and proportion of infants with concentrations of > 0.15µg/mL and ? 1.0µg/mL in the blood samples taken at 5 and 13 months of age. • GMC of IgG to pertussis antigens (PT, PRN, FHA and FIM 2 and 3) in the blood samples taken at 5 months of age. • GMC of anti-tetanus toxoid IgG and proportions =0.1 IU/mL and =1.0 IU/mL in the blood samples taken at 5 months of age. • GMC of anti-diphtheria toxoid IgG and proportions =0.1IU/mL and =1.0 IU/mL in the blood samples taken at 5 months of age. From the nasal swab collected prior to the booster vaccinations at 12 months of age and six months later: • Frequency of carriage of identified pneumococcal serotypes From the health diary completed after each vaccination: • Measurement of redness/ swelling/ pain at the injection site and temperature as recorded in the daily health diary for the week following vaccination, as well as any systemic symptoms. Temperature will also be recorded and analysed from the iButton system ;Timepoint(s) of evaluation of this end point: At various timepoints during the course of the study as per each end point listed - usually in the week following immunisation (AEs) or from the blood samples taken at 5 and or 13 months of age.

—

Countries

United Kingdom

Contacts

Public ContactOxford Vaccine Group

University of Oxford

info@ovg.ox.ac.uk01865857420

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026