Concomitant administration of a fully liquid, ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal serogroup C conjugate vaccine in infants.
Vaccine
; 35(3): 452-458, 2017 01 11.
Article
em En
| MEDLINE
| ID: mdl-27939054
ABSTRACT
DTaP-IPV-HB-PRP-T or hexavalent vaccines are indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The present study evaluates the safety and immunogenicity of a ready-to-use hexavalent vaccine when co-administered with a meningococcal serogroup C conjugate (MenC) vaccine in infants. This was a phase III, open-label, randomised, multicentre study conducted in Finland. Healthy infants, aged 46-74days (n=350), were randomised in a ratio of 11 to receive DTaP-IPV-HB-PRP-T vaccine at two, three and four months, either with a MenC vaccine co-administered at two and four months (Group 1; n=175) or without MenC vaccine (Group 2; n=175). All infants also received routine rotavirus and 13-valent pneumococcal conjugate vaccines. The proportion of participants with an anti-HBs concentration ⩾10mIU/mL assessed one month after the third dose of DTaP-IPV-HB-PRP-T vaccine was 97.5% [95%CI 93.1-99.3] in the coadministration group and 96.1% [95%CI 91.8-98.6] in the group without MenC vaccine. The proportion of participants with an anti-MenC SBA titre ⩾8 assessed one month after the second dose of MenC vaccine was 100% in the coadministration group. Both primary objectives were achieved. Secondary immunogenicity and safety analyses showed that co-administration of DTaP-IPV-HB-PRP-T and MenC vaccines did not impact the immune response to the antigens of each of the two vaccines. All vaccines were well tolerated and the safety profile of DTaP-IPV-HB-PRP-T vaccine was similar in both groups. ClinicalTrials.gov identifier NCT01839175; EudraCT number 2012-005547-24.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Vacina Antipólio de Vírus Inativado
/
Vacina contra Difteria, Tétano e Coqueluche
/
Esquemas de Imunização
/
Vacinas contra Hepatite B
/
Vacinas Anti-Haemophilus
/
Vacinas Meningocócicas
Tipo de estudo:
Clinical_trials
Limite:
Humans
/
Infant
País como assunto:
Europa
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article