Safety, reactogenicity and immunogenicity of a booster dose of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children

Figures & data

Table 1. Incidence of solicited local and general symptoms reported during the 4 d post-vaccination period following PHiD-CV booster dose (total vaccinated cohort)

Symptom	Type	PHiD-CV (n = 141) % [95% CI]
Pain	Any	28.4 (21.1–36.6)
	Grade 3	0.0 (0.0–2.6)
Redness	Any	12.1 (7.2–18.6)
	Grade 3	1.4 (0.2–5.0)
Swelling	Any	47.5 (39.1–56.1)
	Grade 3	0.0 (0.0–2.6)
Drowsiness	Any	0.0 (0.0–2.6)
	Grade 3	0.0 (0.0–2.6)
Fever (Axillary)	Any	24.1 (17.3–32.0)
	Grade 3	0.0 (0.0–2.6)
Irritability	Any	5.7 (2.5–10.9)
	Grade 3	0.0 (0.0–2.6)
Loss of appetite	Any	0.7 (0.0–3.9)
	Grade 3	0.0 (0.0–2.6)

n = number of subjects with the documented dose. Pain of grade 3 intensity, the limb was spontaneously painful or the child cried when the limb was moved passively; grade 3 redness/swelling, diameter > 30mm, drowsiness of grade 3 intensity, prevented normal activity; grade 3 fever > 39.5°C; grade 3 irritability, crying that could not be comforted/prevented normal activity; grade 3 loss of appetite, child did not eat at all; 95% CI = 95% confidence interval.

Figure 2. Kinetics of serotype-specific OPA geometric mean titres (GMTs) for vaccine pneumococcal serotypes and cross-reactive serotypes 6A and 19A, post-primary, pre-booster and post-booster vaccination with PHiD-CV (ATP immunogenicity cohort). ATP, according-to-protocol; OPA , opsonophagocytic activity; GMT, geometric mean titre.

Table 2. Percentage of children with antibody concentrations ≥ 0.2 μg/ml (22F-inhibition ELISA) and OPA titers ≥ 8 for vaccine pneumococcal serotypes and cross-reactive serotypes 6A and 19A, seropositivity rates and GMCs for anti-protein D antibodies pre- and 1 months post-booster dose (ATP immunogenicity cohort)

	ELISA, % ≥ 0.2 μg/ml (95% CI)					OPA, % ≥ 8 (95% CI)
	N	pre-booster	N	post-booster		N	pre-booster	N		post-booster
Vaccine serotypes
1	140	54.3 (45.7–62.7)	139	100 (97.4–100)		139	32.4 (24.7–40.8)	139		97.1 (92.8–99.2)
4	140	59.3 (50.7–67.5)	139	100 (97.4–100)		139	51.1 (42.5–59.6)	139		100 (97.4–100)
5	140	75.0 (67.0–81.9)	139	100 (97.4–100)		133	39.1 (30.8–47.9)	139		100 (97.4–100)
6B	140	86.4 (79.6–91.6)	139	97.8 (93.8–99.6)		116	67.2 (57.9–75.7)	134		98.5 (94.7–99.8)
7F	140	92.1 (86.4–96.0)	139	100 (97.4–100)		133	99.2 (95.9–100)	136		100 (97.3–100)
9V	140	90.0 (83.8–94.4)	139	100 (97.4–100)		100	86.0 (77.6–92.1)	111		100 (96.7–100)
14	140	89.3 (82.9–93.9)	139	99.3 (96.1–100)		112	66.1 (56.5–74.7)	109		99.1 (95.0–100)
18C	140	97.9 (93.9–99.6)	139	100 (97.4–100)		95	14.7 (8.3–23.5)	106		100 (96.6–100)
19F	140	87.1 (80.4–92.2)	139	100 (97.4–100)		124	34.7 (26.4–43.7)	127		98.4 (94.4–99.8)
23F	140	66.4 (58.0–74.2)	139	99.3 (96.1–100)		132	53.8 (44.9–62.5)	137		98.5 (94.8–99.8)
Cross-reactive serotypes
6A	140	40.0 (31.8–48.6)	139	71.9 (63.7–79.2)		127	30.7 (22.8–39.5)		126	58.7 (49.6–67.4)
19A	140	39.3 (31.1–47.9)	139	82.7 (75.4–88.6)		138	16.7 (10.9–24.0)		134	71.6 (63.2–79.1)
Protein D
	≥ 100 EL.U/ml						GMC
	139	89.2 (82.8–93.8)	139		100 (97.4–100)	139	301.1 (257.7–351.8)	139		3710.1 (3109.0–4427.4)

N = number of subjects with available results, 95% CI = 95% confidence interval; ATP, according-to-protocol; 22F-ELISA, 22F-inhibition enzyme-linked immunosorbent assay; OPA, opsonophagocytic activity; GMC, geometric mean titer.

Figure 1. Kinetics of serotype-specific antibody geometric mean concentrations (GMCs, GSK’s 22F-inhibition ELISA) for vaccine pneumococcal serotypes and cross-reactive serotypes 6A and 19A, post-primary, pre-booster and post-booster vaccination with PHiD-CV (ATP immunogenicity cohort). GMC, geometric mean concentration; ATP, according-to-protocol; GSK’s 22F-ELISA, GlaxoSmithKline’s 22F-inhibition enzymelinked immunosorbent assay. Note: Immunogenicity results related to one month post- primary were derived from the primary vaccination study NCT00678301 by re-calculation based on the ATP immunogenicity cohort of the booster study.