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Optimizing primary vaccination schedule for premature infants

Optimizing primary vaccination schedule for premature infants

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21928
Enrollment
300
Registered
2018-06-19
Start date
2015-10-16
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

National immunization program (NIP), preterm infants, immune response

Interventions

No interventions. This is an observational study on immune respons after vaccination in preterm infants according to the current NIP schedule.

Sponsors

Rijksinstituut voor Volksgezondheid en Milieu (RIVM) Antonie van Leeuwenhoeklaan 9 3721 BM Bilthoven 030 - 274 91 11 info@rivm.nl Postadres: Postbus 1 3720 BA Bilthoven
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Eligible for RIVAR study (This study is nested within an observational step-wedged cohort non-WMO study,RIVAR) - Preterm infant (36 weeks of gestational age or younger).-

Exclusion criteria

Exclusion criteria: Not willing to take part in blood sampling

Design outcomes

Primary

MeasureTime frame
Seroconversion rates at 5 and 12 months of age in preterm infants and absolute antibody levels against the regular NIP vaccine components (DTaP, IPV, HIb, HepB and PCV10.

Secondary

MeasureTime frame
- Levels of maternal antibodies at 6 weeks of age - Parameters of cellular immunity at 12 months - Timelines of NIP vaccines - Tolerability and vaccine side effects - Rotavirus seroconversion rates and antibody levels at 5 an 12 months of age among those vaccinated and not-vaccinated against rotavirus.

Contacts

Public ContactLydeke Zwart

Research Support Unit Julius Centrum - UMC Utrecht

Email: rivar@umcutrecht.nlphone: +31 (0) 6 5012 4901

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)