ClinicalTrials.gg
CompletedNCT00197808sched1Updated Oct 1, 2020

Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines

A Phase 4 interventional study of menjugate and Men C conjugate vaccine in Pneumococcal Infections and Meningococcal Infections, sponsored by Public Health England. Completed at 2 sites in United Kingdom. Open to participants aged 7 Weeks to 11 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-01.

Sponsored by Public Health England · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
392
Allocation
Randomized
Ages
7 Weeks to 11 Weeks
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Pneumococcal Infections with a site in United Kingdom — 1 open to participants now, 1 under way, none of them phase 3. Pneumococcal Infections · United Kingdom.

Enrollment
3rd of 10
392 · median 118
Started
2005
the only one that year
Phase 4
5 of 12
1 open now
Registered
1st of 12
by date
Lead sponsor
4 of 12
Public Health England

Among the 12 studies in Pneumococcal Infections with a site in United Kingdom, this one is the 3rd largest by enrollment of the 10 interventional ones, is the only one that started in 2005, is one of 5 in phase 4, and was the 1st registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

Phase 4this study5 · 1 open
Phase 33 · 0 open
Observational2 · 0 open
Phase 11 · 0 open
Phase 21 · 0 open

By the year they started

First in 2005; this study’s year is marked. 1 started in 2005.

Size and results

Median enrollment 118 across the 10 interventional studies, 1,425 across the 2 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.

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02

Study summary

The purpose of the study is to evaluate the immune responses of UK infants after one or two doses of pneumococcal conjugate vaccine or one or two doses of three different types of meningococcal conjugate vaccine given at either two and three or two and four months of age.

03

Conditions studied

  • Pneumococcal Infections
  • Meningococcal Infections

Keywords

  • Streptococcus pneumoniae
  • Neisseria meningitidis
04

Who can participate

Ages eligible
7 Weeks to 11 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written obtained from parent or legal guardian of infant
  • Age 7-11 weeks at first dose

Exclusion criteria

Exclusion Criteria:

  • Any to vaccination as specified in the UK Handbook "Immunisation Against Infectious Disease" (Ed 1996)
  • \< 7 weeks or > 11 weeks at first dose
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
392 participants (actual)

Study arms

  • Experimental
    Vaccine schedule 1

    Menjugate vaccine at 2 and 3 months

    Biological: menjugate

  • Experimental
    Vaccine schedule 2

    Menjugate vaccine at 2 and 4 months

    Biological: Men C conjugate vaccine

  • Experimental
    vaccine schedule3

    Neissvacc at 2 and 3 months

    Biological: Men C conjugate

  • Experimental
    vaccine schedule 4

    Neissvacc at 2 and 4 months

    Biological: Men C Conjugate

  • Experimental
    Vaccine schedule 5

    Meningitec at 2 and 3 months

    Biological: Men C conjugate

  • Experimental
    Vaccine schedule 6

    Meningitec at 2 and 4 months

    Biological: Men C conjugate

Interventions

  • Biologicalmenjugate

    men C conjugate vaccine

  • BiologicalMen C conjugate vaccine

    men C conjugate vaccine

  • BiologicalMen C conjugate

    men C conjugate vaccine

  • BiologicalMen C Conjugate

    men C conjugate vaccine

  • BiologicalMen C conjugate

    men C conjugate vaccine

  • BiologicalMen C conjugate

    men C conjugate vaccine

06

What researchers measure

Primary outcomes

  1. Immunogenicity

    SBA men C responses

    Time frame: 3 months after last sample

07

Study locations

2 sites
  • Hertfordshire Primary Care Trusts
    Welwyn Garden City, Hertfordshire AL8 6JL, United Kingdom
  • Gloucestershire Primary Care Trusts
    Gloucester, GL1 3NN, United Kingdom
08

References and documents

Publications

  • Goldblatt D, Southern J, Ashton L, Richmond P, Burbidge P, Tasevska J, Crowley-Luke A, Andrews N, Morris R, Borrow R, Cartwright K, Miller E. Immunogenicity and boosting after a reduced number of doses of a pneumococcal conjugate vaccine in infants and toddlers. Pediatr Infect Dis J. 2006 Apr;25(4):312-9. doi: 10.1097/01.inf.0000207483.60267.e7. PubMed 16567982 ↗
  • Goldblatt D, Southern J, Ashton L, Andrews N, Woodgate S, Burbidge P, Waight P, Miller E. Immunogenicity of a reduced schedule of pneumococcal conjugate vaccine in healthy infants and correlates of protection for serotype 6B in the United Kingdom. Pediatr Infect Dis J. 2010 May;29(5):401-5. doi: 10.1097/INF.0b013e3181c67f04. PubMed 20010312 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2005, a primary completion of Jan 2010 and a completion of Jan 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2005
First posted
Sep 20, 2005
Start
Apr 2005
Primary completionActual
Jan 2010
CompletionActual
Jan 2010
Last update
Oct 1, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00197808
Lead sponsor
Public Health England
Responsible party
Sponsor
First posted
Sep 20, 2005
Start date
Apr 2005
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Oct 1, 2020

Study contacts

Elizabeth Coates, PhD
study chair · Public Health England
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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