# Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)

> **NCT01480258** · PHASE3 · COMPLETED · sponsor: **MCM Vaccines B.V.** · enrollment: 1315 (actual)

## Conditions studied

- Bacterial Infections
- Virus Diseases

## Interventions

- **BIOLOGICAL:** PR5I
- **BIOLOGICAL:** Rotavirus vaccine
- **BIOLOGICAL:** Prevenar 13™
- **BIOLOGICAL:** INFANRIX™ hexa

## Key facts

- **NCT ID:** NCT01480258
- **Lead sponsor:** MCM Vaccines B.V.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-11-23
- **Primary completion:** 2013-10-09
- **Final completion:** 2013-10-09
- **Target enrollment:** 1315 (ACTUAL)
- **Last updated:** 2019-04-02

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01480258

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01480258, "Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT01480258. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
