A Phase 4 interventional study of Repevax and Boostrix-IPV in Responses to Infant Immunisations, sponsored by Public Health England. Completed at 3 sites in United Kingdom. Open to participants aged 16 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-01.
Sponsored by Public Health England · Phase 4, Interventional, and Prevention
Among 12 studies in Whooping Cough with a site in United Kingdom — none open to participants now, none under way, none of them phase 3. Whooping Cough · United Kingdom.
Among the 12 studies in Whooping Cough with a site in United Kingdom, this one is the only one that started in 2014, is one of 6 in phase 4, and was the 3rd registered.
290 studies on the registry are indexed under Whooping Cough; 23 are open to participants now.
This study's enrollment of 366 is close to the median of 400 across 228 interventional studies indexed under Whooping Cough.
Browse Whooping Cough studies →None of the 12 studies in Whooping Cough with a site in United Kingdom is open now.
Of the 13 Whooping Cough studies recruiting now, 2 (15%) set no upper age limit and 10 (77%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 16 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2014.
Median enrollment 300 across the 9 interventional studies, 50 across the 3 observational. Of the 7 that completed or were terminated, 2 (29%) have results posted.
2 of 12 have an industry lead sponsor. The 5 most frequent:
Public Health England is the lead sponsor of 37 studies on the registry; none are open to participants now.
Public Health England has 3 studies filed under Whooping Cough — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Whooping Cough with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
Due to an unexpectedly high number of infant deaths from whooping cough in 2012, the Department of Health acted to protect newborns between birth and completion of primary immunisations, the period with greatest risk of disease.
Vaccination of pregnant women with whooping cough vaccine in the third trimester of pregnancy was instigated nationally, so that antibodies produced by the Mum would cross the placenta to the unborn child, giving them passive protection at the most vulnerable time. This antibody transfer has been known for some time but has not been compared between the two whooping cough vaccines being used in pregnancy. Any effect the raised antibody might have on infant responses to the vaccines given in the first few months of life has also not been measured. This is particularly important as the infant immunisations include some of the same components as the whooping cough vaccines, which include diphtheria, tetanus and polio. Previous studies have shown that high levels of antibody prior to vaccination may affect subsequent antibody responses. It is therefore important to assess whether administration of the whooping cough vaccine in pregnancy adversely affects the protection afforded by the infant vaccines, particularly to those which are similar, namely tetanus and diphtheria as well as meningitis C and Hib vaccines which include diptheria and tetanus components in their structures. This study will assess immune responses of mothers and their babies (\~200 pairs) to their vaccinations and will allow the comparison of two whooping cough vaccines being used in pregnancy. This will be done by taking small amounts of blood, which is the only way to measure antibody levels (the proxy of the immune response), before and after the vaccinations. A group of unvaccinated women and their babies (50 pairs) will also be recruited to allow comparison of their immune responses.
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.
Pregnant women who, at the time of enrolment
Exclusion Criteria:
Participants may not be included in the study if any of the following apply:
All women:
Women to be vaccinated only (i.e. not the control group):
Fulfil any of the to vaccination specified in The Green Book on Immunisation (https://www.gov.uk/government/organisations/publichealthenglan d/series/immunisationagainstinfectiousdiseasethegreenbook), including:
Infants will be vaccinated under the routine national immunisation schedule in accordance with the inclusion/ exclusion criteria set out in the Department of Health "Green Book"
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Repevax in pregnancy
Drug: Repevax
Boostrix-IPV in pregnancy
Drug: Boostrix-IPV
unvaccinated mothers
vaccine
Also known as: Pertussis containing vaccine
vaccine
Also known as: Pertussis containing vaccine
PT immunogenicity (IgG GMC)
To compare antiPertussis Toxin (PT) IgG responses following primary immunisation with an acellular pertussiscontaining vaccine in infants born to mothers who received REPEVAX in pregnancy compared to infants whose mothers received BOOSTRIXIPV in pregnancy.
Time frame: Birth, 2, 5 and 13 months of age
Immunogenicity of pertussis antigens (IgG GMC)
To compare antibody responses to pertussis antigens (concentration of IgG antibody to PT, pertactin (PRN), filamentous haemagglutinnin (FHA) and fimbrial antigens 2 and 3 (FIM 2 and 3\]), tetanus toxoid and diphtheria toxoid at birth amongst infants born to mothers who received REPEVAX in pregnancy compared to infants whose mothers received BOOSTRIXIPV in pregnancy
Time frame: Birth, 2, 5 and 13 months of age
Immunogenicity of infant immunisations - pertussis antigens, meningococcal serogroup C, pnuemococcal vaccines at 2, 5 and 13 months of age, (all IgG GMC and SBA GMT for MenC)
To compare antibody responses to pertussis antigens \[IgG to PT, PRN, FHA and FIM 2 and 3\], Hib antigen \[PRP\], tetanus toxoid and diphtheria toxoid; meningococcal serogroup C serum bactericidal antibody titres and meningococcal serogroup Cspecific IgG concentrations; 13 serotypespecific pneumococcal IgG concentrations and functional pneumococcal antibody studies at 2, 5 and 13 months of age (just before and one month after primary immunization and one month after booster vaccines) in infants born to mothers who received REPEVAX in pregnancy compared to infants whose mothers received BOOSTRIXIPV in pregnancy and compared to infants whose mothers who did not receive pertussis vaccination in pregnancy
Time frame: Birth, 2, 5 and 13 months of age
immunogenicity of pnuemococcal conjugate vaccine
immunogenicity of pnuemococcal conjugate vaccine
Time frame: birth, 2, 5 13 months
immunogenicity of meningococcal conjugate vaccine
immunogenicity of meningococcal conjugate vaccine
Time frame: birth, 2, 5, 13 months
immunogenicity of diphtheria vaccine
immunogenicity of diphtheria vaccine
Time frame: borth 2, 5, 13 months
immunogenicity of pertussis vaccination
immunogenicity of pertussis vaccination
Time frame: birth, 2, 5, 13 months
Plan to share: No
The record gives a start of Oct 2014, a primary completion of Jun 2017 and a completion of Dec 2017. 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.
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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Public Health England