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Infectious DiseasesPhase 2NCT02482636

Baby Vaccine Study (Sched3)

A Phase 2 study testing DTaP/IPV/Hib vaccine, 13 valent Pneumococcal Conjugate Vaccine and Rotavirus vaccine in people with Infectious Diseases, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This multicentre, parallel group, block randomised clinical trial aims to investigate the post booster antibody response in UK infants given a reduced priming schedule of meningococcal serogroup B vaccine and 13 valent pneumococcal conjugate vaccine. Read more about this study

Who is it for?
Ages 8 to 12 weeksHealthy volunteers can take part
Conditions the study is for
Infectious Diseases
What is being tested?
DTaP/IPV/Hib vaccine, 13 valent Pneumococcal Conjugate Vaccine and Rotavirus vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
1 siteUnited Kingdom
Study dates
Aug 2015to Jun 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Infants due to receive their primary immunisations , aged up to 13 weeks on first vaccinations.
  • Written informed consent given by mother who is aged >= 16 years [NB mother is preferable as consent also allows permission to record the date of pertussis immunisation in pregnancy, which may need to be verified in her medical record. Where mother is not available, consent may be taken from father or legal guardian and maternal pertussis status noted as not known]

Who cannot join

  • Bleeding disorder
  • Fulfil any of the contraindications to vaccination as specified in The Green Book [https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book]:
  • At risk of invasive pneumococcal disease (IPD) as defined in the Green Book pneumococcal chapter 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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Centre for Clinical Vaccinology and Tropical Medicine

    Oxford, Oxfordshire, OX3 7LE

Other trials in United Kingdom

About this study

Official title: Assessment of Post Booster Antibody Responses in UK Infants Given a Reduced Priming Schedule of Meningococcal Serogroup B and 13 Valent Pneumococcal Conjugate Vaccines

This multicentre, parallel group, block randomised clinical trial aims to investigate the post booster antibody response in UK infants given a reduced priming schedule of meningococcal serogroup B vaccine and 13 valent pneumococcal conjugate vaccine. It will provide information about how best to include the meningococcal B vaccine (likely to be introduced late 2015) into the routine immunisation schedule.

The UK Department of Health provides a routine vaccination schedule for children in the UK and are advised by the Joint Committee on Vaccination and Immunisation (JCVI). The Department of Health have announced that the meningococcal B vaccine (Bexsero) be introduced to the routine schedule as a 2+1 schedule. Cost effectiveness could also be improved by removing the current MenC conjugate vaccine dose given at 3 months of age. There is no published immunogenicity data for Bexsero when given at 2, 4 and 12 months of age (2+1 schedule) and with concomitant Infanrix/IPV/Hib which has now replaced Pediacel in the infant programme.

This change to the schedule would result in three injections at 2, 4 and 12 months, and given previous reluctance among parents for three injections at one visit, an option to reduce PCV13 to a 1+1 schedule (priming dose at 3 months and booster at 12 months) will be assessed in this study.

Read the detailed description

The study's primary objective is to assess antibody response to the pneumococcal vaccine after the final infant vaccinations at approximately 13 months of age, and secondary objectives include antibody response following meningococcal B and C vaccines, tetanus, diphtheria and pertussis vaccines. In addition, the effect of maternal pertussis vaccination in pregnancy on infant immune response to vaccines, the prevalence of carriage of pneumococcal serotypes at 12 and 18 months of age and reactogenecity following each vaccine will be assessed.

200 healthy children who have not yet received their routine infant immunisations will be enrolled between 8 and 12 weeks old. Participants will be randomised into one of two groups with differing vaccine schedules. Children in both groups will receive their routine immunisations with the following changes: the addition of 3 doses of a meningococcal B vaccine at 2, 4 and 12 months and a meningococcal C vaccine at 12 months only (instead of a dose at 3 and 12 months). The 2 groups will differ by the number of doses of the 13-valent pneumococcal vaccine (PCV13); to be given either at 2, 4, and 12 months of age (as currently given in the routine schedule) or at 3 and 12 months of age.

Each participant will have 2 blood tests: at 5 and 13 months of age, and 2 nose swabs: at 12 and 18 months of age to address the objectives of the study. Parents will be asked to complete a health diary to record any adverse events in the 7 days following vaccinations and a continuous thermometer (ibutton) will be used to record the temperature for 24 hours after each vaccination.

If the blood samples at 13 months reveal antibody titres that are below the level indicative of protection, a recommendation will be made for booster vaccinations.

Being tested
DTaP/IPV/Hib vaccine, 13 valent Pneumococcal Conjugate Vaccine, Rotavirus vaccine, 4-component Meningococcal B vaccine, Meningococcal C/Hib vaccine (MenC/Hib vaccine)
Keywords
infant immunisations, vaccines, paediatric, pneumococcal, meningococcal
Medical subject headings
Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DTaP/IPV/Hib vaccineBiological

    Also called Infanrix-IPV-Hib

    Given at 2, 3 and 4 months to Group 1 and 2

  • 13 valent Pneumococcal Conjugate VaccineBiological

    Also called PCV 13, Prevenar

    Given at 2,4 and 12 months in group 1, given at 3 and 12 months in group 2

  • Rotavirus vaccineBiological

    Also called Rotarix

    Given at 2 and 3 months to Group 1 and 2

  • 4-component Meningococcal B vaccineBiological

    Also called Bexsero

    Given at 2, 4 and 12 months to Group 1 and 2

  • Meningococcal C/Hib vaccine (MenC/Hib vaccine)Biological

    Also called Menitorix

    Given at 12 months to Group1 and 2

  • Measles/Mumps/Rubella Vaccine (MMR vaccine)Biological

    Also called Priorix, MMR II

    Given at 13 months to Groups 1 and 2

Study groups in NCT02482636
Study groupRoleWhat they receive
Group 1OtherGroup 1 will receive the following interventions: * DTaP/IPV/Hib vaccine IM 0.5ml at 2, 3 and 4 months * 13 valent pneumococcal conjugate vaccine (PCV13) IM 0.5ml at 2, 4 and 12 months * Rotavirus vaccine oral 1.5ml at 2 and 3 months * 4-component Meningococcal B (4CMenB) vaccine IM 0.5ml given at 2, 4 and 12 months * Meningococcal C/Hib vaccine IM 0.5ml at 12 months * Measles/Mumps/Rubella (MMR) vaccine IM 0.5ml at 13 months
Receives: Biological: DTaP/IPV/Hib vaccine; Biological: 13 valent Pneumococcal Conjugate Vaccine; Biological: Rotavirus vaccine; Biological: 4-component Meningococcal B vaccine; Biological: Meningococcal C/Hib vaccine (MenC/Hib vaccine); Biological: Measles/Mumps/Rubella Vaccine (MMR vaccine)
Group 2OtherGroup 2 will receive the following interventions: * DTaP/IPV/Hib vaccine IM 0.5ml at 2, 3 and 4 months * 13 valent pneumococcal conjugate vaccine (PCV13) IM 0.5ml at 3 and 12 months (instead of current routine schedule of 2,4 and 12 months) * Rotavirus vaccine oral 1.5ml at 2 and 3 months * 4-component Meningococcal B (4CMenB) vaccine IM 0.5ml given at 2, 4 and 12 months * Meningococcal C/Hib vaccine IM 0.5ml at 12 months * Measles/Mumps/Rubella (MMR) vaccine IM 0.5ml at 13 months
Receives: Biological: DTaP/IPV/Hib vaccine; Biological: 13 valent Pneumococcal Conjugate Vaccine; Biological: Rotavirus vaccine; Biological: 4-component Meningococcal B vaccine; Biological: Meningococcal C/Hib vaccine (MenC/Hib vaccine); Biological: Measles/Mumps/Rubella Vaccine (MMR vaccine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pneumococcal serotype specific geometric mean concentrations (GMCs) in blood samples following the completion of either a 2, 4 and 12 month schedule of PCV13 vaccination, or only 3 and 12 month PCV13 vaccination

    pneumococcal IgG concentration for the 13 serotypes contained in the vaccine

    Measured: Blood samples collected at 13 months of age

Secondary outcomes (10)

  1. 13 serotype-specific pneumococcal IgG GMCs and functional pneumococcal antibodies and proportions greater than or equal to ≥0.35µg/mL for each serotype in blood samples taken at 5 and 13 months

    Measured: blood samples taken at 5 and 13 months

  2. Titres and proportions of participants achieving antibody responses to MenB vaccination human Serum Bactericidal Antibody (SBA) titres ≥4 for the three main vaccine antigen target MenB strains, 5/99 (NadA), NZ98/254 (PorA) and 44/76-SL (fHbp)

    Measured: Blood samples taken at 5 months

  3. Meningococcal serogroup C human SBA geometric mean titres (GMTs) and proportion of infants ≥4 (5 month blood only); rabbit SBA titres (GMT) and proportion of infants with titres 8 and 128 (13 month blood only)

    Measured: blood samples taken at 5 months and 13 months

  4. Meningococcal serogroup W hSBA GMTs and proportion of infants with titre ≥4 at 5 and 13 months of age

    Measured: blood samples taken at 5 and 13 months

  5. 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

    Measured: Blood samples taken at 5 and 13 months of age

  6. GMC of IgG to pertussis antigens (PT, PRN, FHA and FIM 2 and 3) in the blood samples taken at 5 months of age

    Measured: Blood samples taken at 5 months of age

  7. 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

    Measured: Blood samples taken at 5 months of age

  8. 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

    Measured: blood samples taken at 5 months of age

  9. Frequency of carriage of identified pneumococcal serotypes from the nasal swab collected prior to the booster vaccinations at 12 months of age and six months later

    Measured: Nasal swab taken at 12 months and 18 months

  10. Number of participants with local adverse events at injection site and temperature as recorded in the daily health diary for the week following vaccination and any systemic symptoms. Temperature also recorded and analysed from the iButton system

    Measured: Measurements following vaccinations at 2, 3, 4, 12 and 13 months of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2015 (estimated)
  2. Study startAug 2015
  3. Primary completion1 Nov 2017
  4. Study completionJun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02482636
Sponsor's protocol ID
OVG2015/03
Status last verified
Sep 2021
First submitted
16 Jun 2015
Last updated
20 Sep 2021
Results posted
No
Data monitoring committee
No

Publications

  • Goldblatt D, Southern J, Andrews NJ, Burbidge P, Partington J, Roalfe L, Valente Pinto M, Thalasselis V, Plested E, Richardson H, Snape MD, Miller E. Pneumococcal conjugate vaccine 13 delivered as one primary and one booster dose (1 + 1) compared with two primary doses and a booster (2 + 1) in UK infants: a multicentre, parallel group randomised controlled trial. Lancet Infect Dis. 2018 Feb;18(2):171-179. doi: 10.1016/S1473-3099(17)30654-0. Epub 2017 Nov 22.

    PubMed 29174323

  • Davis K, Valente Pinto M, Andrews NJ, Goldblatt D, Borrow R, Findlow H, Southern J, Partington J, Plested E, Patel S, Holland A, Matheson M, England A, Hallis B, Miller E, Snape MD. Immunogenicity of the UK group B meningococcal vaccine (4CMenB) schedule against groups B and C meningococcal strains (Sched3): outcomes of a multicentre, open-label, randomised controlled trial. Lancet Infect Dis. 2021 May;21(5):688-696. doi: 10.1016/S1473-3099(20)30600-9. Epub 2021 Jan 8.

    PubMed 33428870

  • Valente Pinto M, Davis K, Andrews N, Goldblatt D, Borrow R, Southern J, Nordgren IK, Vipond C, Plested E, Miller E, Snape MD. Understanding the reactogenicity of 4CMenB vaccine: Comparison of a novel and conventional method of assessing post-immunisation fever and correlation with pre-release in vitro pyrogen testing. Vaccine. 2020 Nov 17;38(49):7834-7841. doi: 10.1016/j.vaccine.2020.10.023. Epub 2020 Oct 24.

    PubMed 33109390

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DTaP/IPV/Hib vaccine, 13 valent Pneumococcal Conjugate Vaccine and Rotavirus vaccine in people with Infectious Diseases, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pneumococcal serotype specific geometric mean concentrations (GMCs) in blood samples following the completion of either a 2, 4 and 12 month schedule of PCV13 vaccination, or only 3 and 12 month PCV13 vaccination (time frame: Blood samples collected at 13 months of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02482636, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.

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